Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Phase 1

Terminated

• Conditions: Chronic Hepatitis C
• Interventions: Drug: IDX21459; Drug: Matching Placebo

• Registration Number: NCT02112942
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

All subjects

• Subjects are in good general health.
• Subjects have provided written informed consent form.
• All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects
• Documented clinical history compatible with chronic hepatitis C without cirrhosis.
• Treatment-naïve
• HCV Genotype 1

Exclusion Criteria

All subjects

• Pregnant or breastfeeding
• Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
• Decompensated liver disease
• Other clinically significant medical conditions or laboratory abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	IDX21459	HCV subjects genotype 1, IDX21459 capsules, once for 1 day
Group A	Matching Placebo	Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
Group C	Matching Placebo	HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Group C	IDX21459	HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Group A	IDX21459	Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability assessment	up to 35 days	Proportion of subjects experiencing adverse events.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic	Up to 120 hours post dose	Plasma and urine concentrations of IDX21459 and its metabolite/s.