VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir

NCT01253551 | Completed Phase 1

• 2 other identifiers: CR017608VX-950HEP1001
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.

Conditions

Hepatitis C

Keywords

VX-950HEP1001; hepatitis; telaprevir; raltegravir; crossover; healthy volunteers; VX-950.

Outcome Measures

Primary Outcomes (3)

• Blood levels of telaprevir and raltegravir when given alone versus when given together

  Day 7 of Treatment A

• Blood levels of telaprevir and raltegravir when given alone versus when given together

  Day 4 of Treatment B

• Blood levels of telaprevir and raltegravir when given alone versus when given together

  Day 11 of Treatment B

Secondary Outcomes (8)

• Percentage of participants with a given adverse event as a measure of safety and tolerability

  From screening to end of study

• Clinical laboratory abnormalities as a measure of safety and tolerability

  At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)

• Clinical laboratory abnormalities as a measure of safety and tolerability

  On Days 1 and 7 (Treatment A)

• Clinical laboratory abnormalities as a measure of safety and tolerability

  On Days 1, 4, and 11 (Treatment B)

• Vital signs observed values and changes from baseline as a measure of safety and tolerability

  At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)

Study Arms (2)

001

EXPERIMENTAL

Treatment sequence AB Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.

Drug: Treatment sequence AB

002

EXPERIMENTAL

Treatment sequence BA Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.

Drug: Treatment sequence BA

Interventions

Treatment sequence AB DRUG

Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

001

Treatment sequence BA DRUG

Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

002

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening
• A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
• Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding
• Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug
• Be non-smoking for at least 3 months prior to selection.

You may not qualify if:

• Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication
• Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day
• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
• Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.

Sponsors & Collaborators

• Tibotec BVBA: lead
• Vertex Pharmaceuticals Incorporated: collaborator

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: October 16, 2012

Record last verified: 2012-10