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

• Status: Completed
• Trial end date: 2017-10-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Achaogen, Inc.

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