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

Achaogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: ACHN-383; Drug: ACHN-789

Study type: Interventional

Funder types: Industry

Identifiers

NCT03163550

ACHN-172-001

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: ACHN-789

Drug: Placebo

Drug: ACHN-383

Cohort 2

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: ACHN-789

Drug: Placebo

Drug: ACHN-383

Cohort 3

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: ACHN-789

Drug: Placebo

Drug: ACHN-383

Cohort 4

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: ACHN-789

Drug: Placebo

Drug: ACHN-383

Cohort 5

Experimental group

Description:

Healthy volunteers

Treatment:

Drug: ACHN-789

Drug: Placebo

Drug: ACHN-383