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VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer

Primary Purpose

Hepatitis C, HCV, HIV

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
Sponsored by
Tibotec BVBA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, HCV, HIV, AIDS, Telaprevir, Efavirenz, Tenofovir disproxil fumarate, Healthy volunteer, VX-950-C134, VX-950-TiDP24-C134, HIV Infections

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Females should be post-menopausal (amenorrheal for at least 3 years), or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
  • Normal weight at screening as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
  • Normal 12-lead ECG at screening
  • Healthy on the basis of a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
  • Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening.

Exclusion Criteria:

  • No history or presence of relevant drug or food allergies, cardiovascular or central nervous system disease, clinically significant pathology, mental disease or psychiatric disorders, chronic skin disease, or drug abuse
  • Current use of prescription medication
  • Regular treatment with over-the-counter medications
  • Consumption of herbal medications or dietary supplements
  • A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs
  • Participation in a clinical study within 2 months or 5 half lives of the investigational drug prior to the screening visit
  • No positive HIV test or hepatitis A, B or C infection
  • Having any history of renal disease
  • Male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study drug.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary objectives are to determine the effect of EFV and TDF on the pharmacokinetics of TVR and VRT-127394 and of TVR every 8h and every 12h on the pharmacokinetics of EFV and TDF.

    Secondary Outcome Measures

    The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.

    Full Information

    First Posted
    January 22, 2009
    Last Updated
    December 16, 2010
    Sponsor
    Tibotec BVBA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00828789
    Brief Title
    VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
    Official Title
    A Phase I, Open-label, Randomized, Crossover Trial in 20 Healthy Subjects to Investigate the Pharmacokinetic Interactions Between the Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tibotec BVBA

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will be evaluated.
    Detailed Description
    The trial will enroll 20 Healthy volunteers. All participants will receive 4 different treatments: Treatment A: TVR every 8 hours alone for 6 days with an additional morning intake on Day 7. Treatment B: EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once daily + TDF once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF once daily for 7 days. All participants will start with Treatment A followed by a 7 or 8-day washout period. Subsequently, participants will start with Treatment B. At the end of Treatment B, participants will be randomized (this is assigned to one of the two sequences by chance) to continue without a washout period with Sequence 1 (Treatment C followed by D without a washout) or Sequence 2 (Treatment D followed by C without a washout). Participants will thus receive daily EFV and TDF for a total of 21 consecutive days, with addition of 2 different dosages of TVR for the last 14 days. TVR will be taken with food, 30 minutes after the start of a meal. EFV and TDF should be taken on an empty stomach (2.5 hours after start of breakfast). Pharmacokinetic profiles of TVR and VRT-127394 (R-diastereomer of TVR) will be measured up to 8 hours after intake of the morning dose on Day 7 of Treatments A and C, and up to 12 hours after intake of the morning dose on Day 7 of Treatment D. Pharmacokinetic profiles of EFV and tenofovir will be measured up to 24 hours after intake on Day 7 of Treatments B, C, and D. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period. Treatment A: TVR every 8 hours alone for 6 days with an additional morning intake on Day 7. Treatment B: EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once daily + TDF once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF once daily for 7 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, HCV, HIV, AIDS
    Keywords
    Hepatitis C, HCV, HIV, AIDS, Telaprevir, Efavirenz, Tenofovir disproxil fumarate, Healthy volunteer, VX-950-C134, VX-950-TiDP24-C134, HIV Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
    Primary Outcome Measure Information:
    Title
    The primary objectives are to determine the effect of EFV and TDF on the pharmacokinetics of TVR and VRT-127394 and of TVR every 8h and every 12h on the pharmacokinetics of EFV and TDF.
    Secondary Outcome Measure Information:
    Title
    The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females should be post-menopausal (amenorrheal for at least 3 years), or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral) Normal weight at screening as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to 30 kg/m2, extremes included Normal 12-lead ECG at screening Healthy on the basis of a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening. Exclusion Criteria: No history or presence of relevant drug or food allergies, cardiovascular or central nervous system disease, clinically significant pathology, mental disease or psychiatric disorders, chronic skin disease, or drug abuse Current use of prescription medication Regular treatment with over-the-counter medications Consumption of herbal medications or dietary supplements A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs Participation in a clinical study within 2 months or 5 half lives of the investigational drug prior to the screening visit No positive HIV test or hepatitis A, B or C infection Having any history of renal disease Male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tibotec-Virco Virology BVBA Clinical Trial
    Organizational Affiliation
    Tibotec BVBA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer

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