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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00958152
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:

August 6, 2009
August 13, 2009
January 7, 2010
August 2009
January 2010   (Final data collection date for primary outcome measure)
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events [ Time Frame: Day 47 safety assessment ]
Same as current
Complete list of historical versions of study NCT00958152 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Hepatitis C
  • 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 1
    Interventions:
    • Drug: VCH-222
    • Drug: telaprevir
  • Experimental: Cohort 2
    Interventions:
    • Drug: VCH-222
    • Drug: telaprevir
  • Experimental: Cohort 3
    Interventions:
    • Drug: VCH-222
    • Drug: telaprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
 
NCT00958152
VX09-222-002
Yes
Not Provided
Not Provided
Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP