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

January 25, 2016 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
Drug: Matching Placebo
Drug: IDX21459
Experimental: Group B
HCV subjects genotype 1, IDX21459 capsules, once for 1 day
Drug: IDX21459
Experimental: Group C
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
Drug: Matching Placebo
Drug: IDX21459

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability assessment
Time Frame: up to 35 days
Proportion of subjects experiencing adverse events.
up to 35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic
Time Frame: Up to 120 hours post dose
Plasma and urine concentrations of IDX21459 and its metabolite/s.
Up to 120 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7822-001
  • IDX-04C-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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