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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00958152
First received: August 6, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: VCH-222
Drug: telaprevir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events [ Time Frame: Day 47 safety assessment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: VCH-222
Capsules, Oral, 400 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, 750 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, 1000 mg, q12h, Days 1-10 and Days 28-37
Drug: telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958152

Locations
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00958152     History of Changes
Other Study ID Numbers: VX09-222-002
Study First Received: August 6, 2009
Last Updated: January 6, 2010
Health Authority: New Zealand: Medsafe

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950
VX-222
STAT-C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014