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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163550
Enrollment
40
Registered
2017-05-23
Start date
2017-05-17
Completion date
2017-10-15
Last updated
2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

DRUGACHN-383

Oral dose

DRUGACHN-789

Oral dose

DRUGPlacebo

Oral dose

Sponsors

Achaogen, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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 events26 days
Changes from baseline in the QTcF interval19 days

Secondary

MeasureTime frame
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-7891 day
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-3833 days
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-7891 day
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-3833 days
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-7891 day
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-3833 days
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-7891 day
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-3833 days
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-7891 day
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-3833 days
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-7891 day
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-3833 days
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently1 day
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal6 days
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal6 days
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal6 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 meal6 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 meal6 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 meal6 days
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal6 days
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal6 days
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently19 days
Urine concentrations of ACHN-789 after single dose administration1 day
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-7891 day
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently1 day
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently19 days
Urine concentrations of ACHN-383 after single-dose administration3 days
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-3833 days
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-7891 day
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-3833 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026