Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT03059303
Status:
TERMINATED
Last Update Posted:
2017-12-22
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069616', 'term': 'Simeprevir'}, {'id': 'C000629482', 'term': 'odalasvir'}, {'id': 'C000629483', 'term': 'adafosbuvir'}, {'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'Decision to discontinue development of investigational Hep C treatment regimen JNJ-4178: 3 direct acting antivirals - AL-335, ODV \\& SMV.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of Simeprevir (SMV)', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of SMV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of SMV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of SMV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of SMV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of SMV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of Odalasvir (ODV)', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, 312 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of ODV', 'timeFrame': 'Predose, 1, 2, 4, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, and 312 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of ODV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, 312 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of ODV', 'timeFrame': 'Predose, 1, 2, 4, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, and 312 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, 312 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV', 'timeFrame': 'Predose, 1, 2, 4, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 288, and 312 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'Cmax is defined as the maximum observed plasma concentration.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'AUC (0-last) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \\[non BQL\\]) concentration, calculated by linear trapezoidal summation.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.'}, {'measure': 'Part 1: Analyte Concentration at 1 Hour Post Dosing (C1h) of Lansoprazole', 'timeFrame': 'Day 5 (1 hour post dose)', 'description': 'Analyte Concentration at 1 Hour Post Dosing (C1h) of Lansoprazole'}, {'measure': 'Part 1: Analyte Concentration at 2 Hour Post Dosing (C2h) of Lansoprazole', 'timeFrame': 'Day 5 (2 hour post dose)', 'description': 'Analyte Concentration at 2 Hour Post Dosing (C2h) of Lansoprazole.'}, {'measure': 'Part 1: Analyte Concentration at 1 Hour Post Dosing (C1h) of Omeprazole (if applicable)', 'timeFrame': 'Day 5 (1 hour post dose)', 'description': 'Analyte concentration will only be assessed if participants receive omeprazole (only in case a drug-drug interaction \\[DDI\\] is observed for participants who received lansoprazole).'}, {'measure': 'Part 1: Analyte Concentration at 2 Hour Post Dosing (C2h) of Omeprazole (if applicable)', 'timeFrame': 'Day 5 (2 hour post dose)', 'description': 'Analyte concentration will only be assessed if participants receive omeprazole (only in case an DDI is observed for participants who received lansoprazole).'}], 'secondaryOutcomes': [{'measure': 'Part 2: Exposure as Measured by AUC From 2 Different Fixed Dose Combination Formulations containing odalasvir (ODV) (Treatment F Versus Treatment A2)', 'timeFrame': 'Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose', 'description': 'Exposure will be measured by AUC.'}, {'measure': 'Part 1 and 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Screening (21 days prior to the first dose) to follow up Phase (30 to 35 days after last dose)', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, irrespective of a causal relationship with the investigational product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC) compared with the single agents when administered together, and to assess the effect of multiple-dose lansoprazole and omeprazole on the single-dose pharmacokinetics (PK) of SMV, ODV, and AL-335 when administered as an FDC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of 18.0 to 32.0 kilogram per meter (kg/m\\^2), extremes included, and a body weight not less than 50.0 kg\n* Participant must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted. Participants with a normal value at retest may be included\n* Participant must have a normal 12-lead Electrocardiogram \\[ECG\\] (based on the mean value of triplicate ECG parameters) consistent with normal cardiac conduction and function at screening, including:a) normal sinus rhythm (heart rate (HR) between 60 and 90 beats per minute \\[bpm\\], extremes included); b) QT interval corrected for heart rate according to Fridericia's formula (QTcF) less than or equal to \\<=450 milliseconds (ms) for male participants and \\<=470 ms for female participants; c) QRS interval \\<=110 ms; d) PR interval \\<=200 ms; e) Electrocardiogram (ECG) morphology consistent with healthy cardiac conduction and function. Any evidence of heart block is exclusionary. Any evidence of left or right bundle branch block is exclusionary\n* Female participant must have a negative highly sensitive urine or serum pregnancy test at Day -1\n\nExclusion Criteria:\n\n* Participant with a past history of: a) Heart arrhythmias (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary; b) Risk factors associated with Torsade de Pointes such as hypokalemia; c) Family history of short/long QT syndrome; d) Sudden unexplained death (including sudden infant death syndrome) in a first degree relative (that is, sibling, offspring, or biological parent)\n* Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV), AL-335, simeprevir (SMV), lansoprazole, or omeprazole, or their excipients\n* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening\n* Participant has a history of human immunodeficiency virus (HIV-1) or -2 infection positive, or tests positive for HIV-1 or -2 at screening\n* Participant has previously been dosed with SMV, ODV, or AL-335 in more than 3 single-dose studies or in a multiple dose study with SMV, ODV, or AL-335"}, 'identificationModule': {'nctId': 'NCT03059303', 'briefTitle': 'Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'Phase 1, Open-label, Partially Randomized, Parallel-group Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 Administered as a Fixed-dose Combination (FDC) Compared With the Single Agents Administered Together, and to Assess the Effect of Multiple-dose Lansoprazole or Omeprazole on the Single-dose Pharmacokinetics of SMV, ODV, and AL-335 Administered as an FDC', 'orgStudyIdInfo': {'id': 'CR108273'}, 'secondaryIdInfos': [{'id': '64294178HPC1018', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Treatment A: FDC [SMV(75mg)+ODV(25mg)+AL-335(800mg)]', 'description': 'Participants will receive single oral dose of simeprevir (SMV) 75 milligram (mg), odalasvir (ODV) 25 mg, and AL-335 800 mg, given as a fixed-dose combination (FDC) tablet (G008 formulation) after a standardized breakfast on Day 1.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Treatment B: FDC [SMV(75mg)+ODV(12.5mg)+AL-335(800mg)]', 'description': 'Participants will receive single oral dose of SMV 75 mg, ODV 12.5 mg, and AL-335 800 mg, given as an FDC tablet (G007 formulation) after a standardized breakfast on Day 1.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 12.5 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Treatment C: Simeprevir, Odalasvir, and AL-335', 'description': 'Participants will receive single oral dose of 75 mg SMV, 25 mg ODV, and 800 mg AL-335, given as 3 single agents after a standardized breakfast on Day 1.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Treatment D: Lansoprazole + FDC [SMV+ODV+AL-335]', 'description': 'Participants will receive 30 mg lansoprazole once daily in the morning under fasted conditions on Days 1 to 4, and together with a single oral dose of an FDC containing 75 mg SMV, 25 mg ODV, and 800 mg AL-335 (G008 formulation) after a standardized breakfast, which is served 2 hours after lansoprazole dosing, on Day 5.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg', 'Drug: Lansoprazole 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Treatment E: Omeprazole + FDC [SMV+ODV+AL-335]', 'description': 'Participants will receive 20 mg omeprazole once daily in the morning immediately before a (non-standardized) breakfast on Days 1 to 4, and immediately before a standardized breakfast and within 1 hour before a single oral dose of an FDC containing 75 mg SMV, 25 mg ODV, and 800 mg AL-335 (G008 formulation) after a standardized breakfast on Day 5. Treatment E will only be started in case a drug-drug interaction (DDI) is observed for Treatment D.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg', 'Drug: Omeprazole 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence A2-F', 'description': 'Participants will receive single oral dose of simeprevir (SMV) 75 milligram (mg), odalasvir (ODV) 25 mg, and AL-335 800 mg, given as an FDC (Treatment A2 - G008 formulation) on Day 1 of Period 1, and then single oral dose of SMV 75 mg, ODV 25 mg, and AL-335 800 mg, given as an FDC (Treatment F - G012 formulation) on Day 1 of Period 2, under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence F-A2', 'description': 'Participants will receive Treatment F on Day 1 of Period 1 and then Treatment A2 on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence C2-F', 'description': 'Participants will receive single oral dose of 75 mg SMV, 25 mg ODV, and 800 mg AL-335, given as 3 single agents (Treatment C2) on Day 1 of Period 1 and then Treatment F on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence F-C2', 'description': 'Participants will receive Treatment F on Day 1 of Period 1 and then Treatment C2 on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence C2-G', 'description': 'Participants will receive Treatment C2 on Day 1 of Period 1 and then 2 tablets of SMV 37.5 mg, ODV 37.5 mg, and AL-335 400 mg, given as FDC (Treatment G - G013 formulation) on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: Odalasvir 75 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence G-C2', 'description': 'Participants will receive Treatment G on Day 1 of Period 1 and then Treatment C2 on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: Odalasvir 75 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence F-G', 'description': 'Participants will receive Treatment F on Day 1 of Period 1 and then Treatment G on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: Odalasvir 75 mg', 'Drug: AL-335 800 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence G-F', 'description': 'Participants will receive Treatment G on Day 1 of Period 1 and then Treatment F on Day 1 of Period 2 under fed condition (after a standardized breakfast). A washout period of at least 2 weeks will be maintained between each treatment.', 'interventionNames': ['Drug: Simeprevir 75 mg', 'Drug: Odalasvir 25 mg', 'Drug: Odalasvir 75 mg', 'Drug: AL-335 800 mg']}], 'interventions': [{'name': 'Simeprevir 75 mg', 'type': 'DRUG', 'description': 'Part 1: Simeprevir (SMV) 75 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent capsule in Treatment C.\n\nPart 2: SMV 75 mg taken orally as a component of FDC tablet in Treatment A2, F (2 tablets of 37.5 mg each), and G (2 tablets of 37.5 mg each), and as a single agent capsule in Treatment C2.', 'armGroupLabels': ['Part 1: Treatment A: FDC [SMV(75mg)+ODV(25mg)+AL-335(800mg)]', 'Part 1: Treatment B: FDC [SMV(75mg)+ODV(12.5mg)+AL-335(800mg)]', 'Part 1: Treatment C: Simeprevir, Odalasvir, and AL-335', 'Part 1: Treatment D: Lansoprazole + FDC [SMV+ODV+AL-335]', 'Part 1: Treatment E: Omeprazole + FDC [SMV+ODV+AL-335]', 'Part 2: Treatment Sequence A2-F', 'Part 2: Treatment Sequence C2-F', 'Part 2: Treatment Sequence C2-G', 'Part 2: Treatment Sequence F-A2', 'Part 2: Treatment Sequence F-C2', 'Part 2: Treatment Sequence F-G', 'Part 2: Treatment Sequence G-C2', 'Part 2: Treatment Sequence G-F']}, {'name': 'Odalasvir 25 mg', 'type': 'DRUG', 'description': 'Part 1: Odalasvir (ODV) 25 mg taken orally as a component of FDC tablet in Treatment A, D and E and as a single agent tablet in Treatment C.\n\nPart 2: ODV 25 mg taken orally as a component of FDC tablet in Treatment A2 and F (2-tablets of 12.5 mg each), and as a single agent tablet in Treatment C2.', 'armGroupLabels': ['Part 1: Treatment A: FDC [SMV(75mg)+ODV(25mg)+AL-335(800mg)]', 'Part 1: Treatment C: Simeprevir, Odalasvir, and AL-335', 'Part 1: Treatment D: Lansoprazole + FDC [SMV+ODV+AL-335]', 'Part 1: Treatment E: Omeprazole + FDC [SMV+ODV+AL-335]', 'Part 2: Treatment Sequence A2-F', 'Part 2: Treatment Sequence C2-F', 'Part 2: Treatment Sequence C2-G', 'Part 2: Treatment Sequence F-A2', 'Part 2: Treatment Sequence F-C2', 'Part 2: Treatment Sequence F-G', 'Part 2: Treatment Sequence G-C2', 'Part 2: Treatment Sequence G-F']}, {'name': 'Odalasvir 12.5 mg', 'type': 'DRUG', 'description': 'Part 1: ODV 12.5 mg taken orally as a component of FDC tablet in Treatment B.', 'armGroupLabels': ['Part 1: Treatment B: FDC [SMV(75mg)+ODV(12.5mg)+AL-335(800mg)]']}, {'name': 'Odalasvir 75 mg', 'type': 'DRUG', 'description': 'Part 2: ODV 75 mg taken orally as a component of FDC tablet (2 tablets of 37.5 mg each) in Treatment G.', 'armGroupLabels': ['Part 2: Treatment Sequence C2-G', 'Part 2: Treatment Sequence F-G', 'Part 2: Treatment Sequence G-C2', 'Part 2: Treatment Sequence G-F']}, {'name': 'AL-335 800 mg', 'type': 'DRUG', 'description': 'Part 1: AL-335 800 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent tablet in Treatment C.\n\nPart 2: AL-335 800 mg taken orally as a component of FDC tablet in Treatment A2, F (2 tablets of 400 mg each), and G (2 tablets of 400 mg each) and as a single agent tablet in Treatment C2.', 'armGroupLabels': ['Part 1: Treatment A: FDC [SMV(75mg)+ODV(25mg)+AL-335(800mg)]', 'Part 1: Treatment B: FDC [SMV(75mg)+ODV(12.5mg)+AL-335(800mg)]', 'Part 1: Treatment C: Simeprevir, Odalasvir, and AL-335', 'Part 1: Treatment D: Lansoprazole + FDC [SMV+ODV+AL-335]', 'Part 1: Treatment E: Omeprazole + FDC [SMV+ODV+AL-335]', 'Part 2: Treatment Sequence A2-F', 'Part 2: Treatment Sequence C2-F', 'Part 2: Treatment Sequence C2-G', 'Part 2: Treatment Sequence F-A2', 'Part 2: Treatment Sequence F-C2', 'Part 2: Treatment Sequence F-G', 'Part 2: Treatment Sequence G-C2', 'Part 2: Treatment Sequence G-F']}, {'name': 'Lansoprazole 30 mg', 'type': 'DRUG', 'otherNames': ['Prevacid'], 'description': '30 mg lansoprazole once daily from Day 1 to Day 5.', 'armGroupLabels': ['Part 1: Treatment D: Lansoprazole + FDC [SMV+ODV+AL-335]']}, {'name': 'Omeprazole 20 mg', 'type': 'DRUG', 'description': '20 mg omeprazole once daily from Day 1 to Day 5.', 'armGroupLabels': ['Part 1: Treatment E: Omeprazole + FDC [SMV+ODV+AL-335]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}