Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 5:07 AM
Study NCT ID:
NCT03163550
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-20', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)', 'timeFrame': '26 days'}, {'measure': 'Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)', 'timeFrame': '26 days'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': '26 days'}, {'measure': 'Changes from baseline in the QTcF interval', 'timeFrame': '19 days'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383', 'timeFrame': '3 days'}, {'measure': 'PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '1 day'}, {'measure': 'PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '5 days'}, {'measure': 'PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal', 'timeFrame': '6 days'}, {'measure': 'PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently', 'timeFrame': '19 days'}, {'measure': 'Urine concentrations of ACHN-789 after single dose administration', 'timeFrame': '1 day'}, {'measure': 'Urine concentrations of ACHN-383 after single-dose administration', 'timeFrame': '3 days'}, {'measure': 'Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently', 'timeFrame': '1 day'}, {'measure': 'Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently', 'timeFrame': '5 days'}, {'measure': 'Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently', 'timeFrame': '19 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug\n* Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile\n* Body mass index (BMI) of ≥19 kg/m\\^2 to ≤32 kg/m\\^2 and weight ≥50 kg to ≤125 kg\n* Normal renal function as determined by creatinine clearance (CLcr) rate\n\nKey Exclusion Criteria:\n\n* Pregnant women\n* History of any hepatic or biliary disorder or disease\n* Any condition that could possibly affect oral drug absorption\n* Unstable cardiovascular disease\n* Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder\n* HIV positive\n* Active malignancy'}, 'identificationModule': {'nctId': 'NCT03163550', 'briefTitle': 'A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789', 'organization': {'class': 'INDUSTRY', 'fullName': 'Achaogen, Inc.'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ACHN-172-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: ACHN-383', 'Drug: ACHN-789', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: ACHN-383', 'Drug: ACHN-789', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: ACHN-383', 'Drug: ACHN-789', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: ACHN-383', 'Drug: ACHN-789', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'Healthy volunteers', 'interventionNames': ['Drug: ACHN-383', 'Drug: ACHN-789', 'Drug: Placebo']}], 'interventions': [{'name': 'ACHN-383', 'type': 'DRUG', 'description': 'Oral dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}, {'name': 'ACHN-789', 'type': 'DRUG', 'description': 'Oral dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perth', 'country': 'Australia', 'facility': 'Clinical Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Daniel J Cloutier, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Achaogen, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Achaogen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}