A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789

Achaogen, Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ACHN-383DRUG

Oral dose

ACHN-789DRUG

Oral dose

PlaceboDRUG

Oral dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Site

Perth, Australia

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

Time frame: 1 day

PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383

Time frame: 3 days

Data from ClinicalTrials.gov

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PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789

PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789

Time frame: 1 day

PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383

Time frame: 3 days

PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 5 days

PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 1 day

PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 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

Time frame: 6 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

Time frame: 6 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

Time frame: 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

Time frame: 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

Time frame: 6 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

Time frame: 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

Time frame: 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

Time frame: 6 days

PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently

Time frame: 19 days

Urine concentrations of ACHN-789 after single dose administration

Time frame: 1 day

Urine concentrations of ACHN-383 after single-dose administration

Time frame: 3 days

Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently

Time frame: 1 day

Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently

Time frame: 5 days

Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently

Time frame: 19 days