Clinical trial NCT03163550: A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Clinical Site
Study officials:
affiliation: Achaogen, Inc.
name: Daniel J Cloutier, PharmD
role: STUDY_DIRECTOR
References: