NCT03163550
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ACHN-383
- Conditions
- Healthy Volunteers
- Sponsor
- Achaogen, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Cohort 1
Healthy volunteers
Intervention: ACHN-383
Cohort 1
Healthy volunteers
Intervention: ACHN-789
Cohort 1
Healthy volunteers
Intervention: Placebo
Cohort 2
Healthy volunteers
Intervention: ACHN-383
Cohort 2
Healthy volunteers
Intervention: ACHN-789
Cohort 2
Healthy volunteers
Intervention: Placebo
Cohort 3
Healthy volunteers
Intervention: ACHN-383
Cohort 3
Healthy volunteers
Intervention: ACHN-789
Cohort 3
Healthy volunteers
Intervention: Placebo
Cohort 4
Healthy volunteers
Intervention: ACHN-383
Cohort 4
Healthy volunteers
Intervention: ACHN-789
Cohort 4
Healthy volunteers
Intervention: Placebo
Cohort 5
Healthy volunteers
Intervention: ACHN-383
Cohort 5
Healthy volunteers
Intervention: ACHN-789
Cohort 5
Healthy volunteers
Intervention: Placebo
Outcomes
Primary Outcomes
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
Time Frame: 26 days
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
Time Frame: 26 days
Incidence and severity of adverse events
Time Frame: 26 days
Changes from baseline in the QTcF interval
Time Frame: 19 days
Secondary Outcomes
- 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: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently(19 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: 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: 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: 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: 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: 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)
Study Sites (1)
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