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

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ClinicalTrials.gov Identifier: NCT00958152
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: VCH-222 Drug: telaprevir Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958152


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

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
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: January 2010

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

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