A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: ACHN-383Drug: ACHN-789Drug: Placebo
- Registration Number
- NCT03163550
- Lead Sponsor
- Achaogen, Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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
- 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
- Body mass index (BMI) of ≥19 kg/m^2 to ≤32 kg/m^2 and weight ≥50 kg to ≤125 kg
- Normal renal function as determined by creatinine clearance (CLcr) rate
Key
Exclusion Criteria
- Pregnant women
- History of any hepatic or biliary disorder or disease
- Any condition that could possibly affect oral drug absorption
- Unstable cardiovascular disease
- Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- HIV positive
- Active malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5 ACHN-383 Healthy volunteers Cohort 3 ACHN-383 Healthy volunteers Cohort 3 Placebo Healthy volunteers Cohort 2 ACHN-789 Healthy volunteers Cohort 2 Placebo Healthy volunteers Cohort 4 ACHN-383 Healthy volunteers Cohort 4 ACHN-789 Healthy volunteers Cohort 4 Placebo Healthy volunteers Cohort 1 ACHN-789 Healthy volunteers Cohort 1 Placebo Healthy volunteers Cohort 2 ACHN-383 Healthy volunteers Cohort 3 ACHN-789 Healthy volunteers Cohort 1 ACHN-383 Healthy volunteers Cohort 5 ACHN-789 Healthy volunteers Cohort 5 Placebo Healthy volunteers
- Primary Outcome Measures
Name Time Method Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin) 26 days Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure) 26 days Incidence and severity of adverse events 26 days Changes from baseline in the QTcF interval 19 days
- Secondary Outcome Measures
Name Time Method PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789 1 day PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789 1 day PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383 3 days PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789 1 day PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383 3 days PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal 6 days 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 6 days PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal 6 days PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383 3 days PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383 3 days PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789 1 day PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789 1 day PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal 6 days 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 6 days PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days Urine concentrations of ACHN-789 after single dose administration 1 day PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789 1 day PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383 3 days PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal 6 days PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal 6 days PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789 1 day PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383 3 days PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789 1 day PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383 3 days PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383 3 days PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 5 days 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 6 days PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently 19 days PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days Urine concentrations of ACHN-383 after single-dose administration 3 days PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently 19 days Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently 5 days
Trial Locations
- Locations (1)
Clinical Site
🇦🇺Perth, Australia