Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-11 @ 6:17 AM
Study NCT ID:
NCT04265456
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2020-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D011456', 'term': 'Prostaglandins B'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Up to 60 healthy male and female volunteers will be enrolled into one (1) of up to six (6) cohorts (n=10 per cohort).\n\nWithin each cohort, subjects will be randomized at a ratio of 4:1 to receive IP (1300 mg of IV APAP plus a cohort specific dose of IV PGB) or placebo (saline) (8 active:2 placebo).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Related Adverse Events', 'timeFrame': '7 days', 'description': 'The incidence and severity of treatment-emergent adverse events'}, {'measure': 'Treatment related Drowsiness and Dizziness', 'timeFrame': '7 days', 'description': 'The incidence and severity of somnolence and dizziness'}], 'secondaryOutcomes': [{'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, Cmax', 'timeFrame': '7 days', 'description': 'Maximum observed concentration'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, Tmax', 'timeFrame': '7 days', 'description': 'Time to maximum observed drug concentration (Tmax)'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, t1/2', 'timeFrame': '7 days', 'description': 'Apparent elimination half-life'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-last', 'timeFrame': '7 days', 'description': 'Area under the drug concentration-time curve from time zero to the last measurable concentration'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-inf', 'timeFrame': '7 days', 'description': 'AUC from time zero to infinity'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, λz', 'timeFrame': '7 days', 'description': 'Apparent terminal elimination rate constant'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, CL', 'timeFrame': '7 days', 'description': 'Apparent clearance'}, {'measure': 'Plasma PK endpoints for APAP and PGB, SAD Phase, Vz', 'timeFrame': '7 days', 'description': 'Apparent terminal volume of distribution'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, AUCτ', 'timeFrame': '7 days', 'description': 'Area under the plasma concentration-time curve during a dosage interval'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Tmax,ss', 'timeFrame': '7 days', 'description': 'Time to Cmax at SS'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmax,ss', 'timeFrame': '7 days', 'description': 'Maximum concentration at SS'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmin,ss', 'timeFrame': '7 dyas', 'description': 'Minimum concentration at ss'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cav,ss', 'timeFrame': '7 days', 'description': 'Average plasma concentration at SS'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Vz, ss', 'timeFrame': '7 days', 'description': 'Apparent volume of distribution at SS'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, CLss', 'timeFrame': '7 days', 'description': 'Apparent total clearance at SS'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, λz,ss', 'timeFrame': '7 days', 'description': 'Apparent first order terminal elimination rate constant at steady state'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, R', 'timeFrame': '7 days', 'description': 'Accumulation index'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state, LF', 'timeFrame': '7 days', 'description': 'Linearity factor'}, {'measure': 'Plasma PK endpoints for APAP and PGB, multiple doses at steady state', 'timeFrame': '7 days', 'description': 'Fluctuation ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.', 'detailedDescription': 'This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose (MTD) of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.\n\nUp to 60 subjects will be enrolled into one (1) of six (6) sequential cohorts (n=10 per cohort \\[8 APAP + PGB and 2 placebo\\]).\n\nThe dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg) based on Safety Monitoring Committee decision.\n\nThe placebo will be the saline solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 55 years, inclusive at time of Screening\n* Body mass index (BMI) between 18.5 and 28.0 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg\n* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG confirming normal sinus rhythm\n* Negative tests for Hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening\n* Routine clinical laboratory tests should be within normal limits at Screening and Admission (Day -1) or abnormalities deemed not clinically significant by the Investigator; for liver function tests, AST and ALT values should not be greater than 1.5 times the upper limit of normal range\n* Negative screen for drugs of abuse or exhibit detectable alcohol levels by breathalyzer at the time of Screening or Admission\n* Non-smokers or ex-smokers (must have ceased smoking ≥3 months prior Screening visit)\n\nFemale subjects:\n\n* Must be of non-childbearing potential by surgical sterilization or postmenopausal OR Must not be pregnant, breast feeding, or planning to become pregnant AND must be practicing both a highly effective method of birth control from Screening until at least 90 days after the last dose of study drug.\n* Women of childbearing potential must have a negative pregnancy test result at Screening and upon admission to the Clinical Trial Unit.\n\nExclusion Criteria:\n\n* Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders\n* Has a history of severe drug allergy, or severe hypersensitivity or severe food allergy, including anaphylaxis or known allergy or sensitivity to any component of PGB or APAP\n* Has a history of alcoholism or drug abuse\n* Has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) at the time of Screening or Admission\n* Consumption of drugs with enzyme-inducing properties, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase\n* Has used any prescription medicines, over the counter medicines, or herbal supplements, within 7 days of dosing\n* Has used any investigational product or participated in any clinical trial within 30 days prior to Screening\n* Has donated or received any blood or blood products within the 3 months prior to Screening;\n* Not able to comply with the requirements of this study, including assessments, duration of admission of the study and expected follow up visits\n* Is unwilling or unable to give written informed consent'}, 'identificationModule': {'nctId': 'NCT04265456', 'briefTitle': 'A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nevakar, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CP-NVK009-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1300 mg Acetaminophen and 100 mg IV Pregabalin', 'description': 'The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg based on Safety Monitoring Committee decision).', 'interventionNames': ['Drug: Pregabalin 100mg', 'Drug: Acetaminophen 1300mg']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': 'Saline solution'}, {'type': 'EXPERIMENTAL', 'label': '1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin', 'description': 'Decisions to escalate or decrease the dose for Cohorts 2 through 6 will be dependent upon blinded review of emerging safety and tolerability data by the Safety Monitoring Committee (SMC). However, PK data is not part of the SMC review, but may be reviewed by a SMC designee at a later time.', 'interventionNames': ['Drug: Pregabalin 100mg', 'Drug: Acetaminophen 1300mg']}], 'interventions': [{'name': 'Pregabalin 100mg', 'type': 'DRUG', 'otherNames': ['PGB'], 'description': 'Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.', 'armGroupLabels': ['1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin', '1300 mg Acetaminophen and 100 mg IV Pregabalin']}, {'name': 'Acetaminophen 1300mg', 'type': 'DRUG', 'otherNames': ['Ofirmev'], 'description': 'Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.', 'armGroupLabels': ['1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin', '1300 mg Acetaminophen and 100 mg IV Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Resarch,LLC', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nevakar, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}