A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
NCT03163550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-12-02
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
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
ACHN-383
Oral dose
- DRUG
-
ACHN-789
Oral dose
- DRUG
-
Oral dose
Sponsors & Collaborators
-
Achaogen, Inc.
lead INDUSTRY
Principal Investigators
-
Daniel J Cloutier, PharmD · Achaogen, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-17
- Primary Completion
- 2017-10-15
- Completion
- 2017-10-15
Countries
- Australia
Study Locations
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