VX-950-TiDP24-C136 - A Trial to Evaluate the Effect of Telaprevir (TVR) on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

NCT00973388 | Completed Phase 1

• 1 other identifier: CR016417
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection.

Conditions

Hepatitis C

Keywords

VX-950-TiDP24-C136; VX-950-C136; VX-950; HEPATITIS; Telaprevir; Moxifloxacin; ECG; QT; QTc

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate the effect of administration of TVR 750 mg every 8 hours and 1875 mg every 8 hours, both at steady-state, versus placebo on the QT and QTc interval (heart activity) in healthy volunteers.

  For each dosing period, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.

Secondary Outcomes (5)

• Trial sensitivity will be evaluated (i.e., the effect of a positive control, a single 400 mg dose of moxifloxacin, on the QT/QTc interval).

  In treatment session C, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.

• The effect of 2 different regimens of TVR on non-QT interval electrocardiogram (ECG) parameters (RR interval, HR, PR interval, and QRS interval) will be evaluated.

  In treatment session A and B, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.

• The pharmacokinetics of 2 dose regimens of TVR, 750 mg every 8 hours and 1875 mg every 8 hours, at steady-state will be evaluated.

  Samples to access pharmacokinetics of TVR will be collected on Days -1 and 5 of each treatment session (8 times sampling in a period of 9 hours), as well as predose on Days 2, 3 and 4 of each treatment session.

• The concentration-effect relationship for QT/QTc for TVR will be explored.

  In each treatment session, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.

• The short-term safety and tolerability of 2 dose regimens of TVR, 750 mg and 1875 mg every 8 hours will be evaluated.

  Safety will be assessed from screening until the last trial related visit (approximately 15 weeks). Tolerability will be evaluated from the first dosing in the first treatment session until the last trial related visit (approximately 12 weeks).

Interventions

Telaprevir; Moxifloxacin; Placebo DRUG

Eligibility Criteria

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

You may qualify if:

• Non-smoking for at least 6 months prior to screening
• A body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to30 kg/m2, extremes included
• Otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of laboratory tests and a urinalysis carried out at screening

You may not qualify if:

• Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week from 14 days before the first intake of study medication and of an average of more than five 240-mL servings of coffee or other caffeinated beverage (e.g. tea, cola) per day from screening onwards
• A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs during the screening period
• Participation in a clinical study involving administration of an investigational drug within 2 months or 5 half lives (whichever is longer) prior to the screening visit
• Donation of any blood or having had a significant loss of blood within 3 months, or donation of more than 1 unit of plasma within 7 days before the first dose of study drug
• Male patients with female partners who are planning to become pregnant during the study or within 90 days of the last dose of study medication and female patients of childbearing potential who are pregnant or planning to become pregnant within 90 days of the completion of the study, who are not using adequate contraception, or who are breastfeeding

Sponsors & Collaborators

• Tibotec BVBA: lead
• Vertex Pharmaceuticals Incorporated: collaborator

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Interventions

telaprevir; Moxifloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 9, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 17, 2010

Record last verified: 2010-12