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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00958152

Enrollment

Registered

2009-08-13

Start date

2009-08-31

Completion date

2010-01-31

Last updated

2010-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

VX-950, VX-222, STAT-C

Brief summary

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.

Interventions

DRUGVCH-222

Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37

DRUGtelaprevir

Tablet, Oral, 1125 mg, q12h, Days 18-37

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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	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	Day 37 pharmacokinetic assessment

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026