Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

January 6, 2010 updated by: Vertex Pharmaceuticals Incorporated

A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
  • Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg

Exclusion Criteria:

  • Women of child bearing potential
  • Subjects positive for Hepatitis B, Hepatitis C, or HIV
  • Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Drug: VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
Drug: telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Experimental: Cohort 2
Drug: VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
Drug: telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Experimental: Cohort 3
Drug: VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
Drug: VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
Drug: telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Time Frame: Day 47 safety assessment
Day 47 safety assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
Time Frame: Day 37 pharmacokinetic assessment
Day 37 pharmacokinetic assessment
Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
Time Frame: Day 37 pharmacokinetic assessment
Day 37 pharmacokinetic assessment

Collaborators and Investigators

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

Sponsor

Vertex Pharmaceuticals Incorporated

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

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX09-222-002

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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