A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects

A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: telaprevir formulation A; Drug: telaprevir Formulation B; Drug: telaprevir Formulation C; Drug: telaprevir Formulation D

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Texas
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
• Non-childbearing potential female subjects
• Male subjects and female partners must agree to use at least 2 methods of contraception
• Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.

Exclusion Criteria:

• Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
• Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
• Subjects with a positive urine screen for drugs of abuse
• Subjects with a history of regular alcohol consumption
• Subjects treated with an investigational drug within 30 days
• For Part A only: Subjects with 12-lead ECG QTcF >450 msec (males) or QTcF >470 msec (females) at the Screening Visit
• Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
• Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
• Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
• Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
• Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.	Drug: telaprevir formulation A; A single 1125-mg dose administered orally; Drug: telaprevir Formulation B; A single 1125-mg dose administered orally; Drug: telaprevir Formulation C; A single 1125-mg dose administered orally; Drug: telaprevir Formulation D; A single 1125-mg dose administered orally
Experimental: Part B; Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state	Drug: telaprevir formulation A; A single 1125-mg dose administered orally; Drug: telaprevir Formulation B; A single 1125-mg dose administered orally; Drug: telaprevir Formulation C; A single 1125-mg dose administered orally; Drug: telaprevir Formulation D; A single 1125-mg dose administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)	Up to 57 days
• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)	Up to 57 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms	Up to 57days
Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir	Up to 57 Days

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Relative bioavailability; telaprevir formulations
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: VX11-950-025