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

NCT01511432 | Completed Phase 1

• 1 other identifier: VX11-950-025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Hepatitis C

Keywords

Relative bioavailability; telaprevir formulations

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Part A

EXPERIMENTAL

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; Drug: telaprevir Formulation B; Drug: telaprevir Formulation C; Drug: telaprevir Formulation D

Part B

EXPERIMENTAL

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; Drug: telaprevir Formulation B; Drug: telaprevir Formulation C; Drug: telaprevir Formulation D

Interventions

telaprevir formulation A DRUG

A single 1125-mg dose administered orally

Part A; Part B

telaprevir Formulation B DRUG

A single 1125-mg dose administered orally

Part A; Part B

telaprevir Formulation C DRUG

A single 1125-mg dose administered orally

Part A; Part B

telaprevir Formulation D DRUG

A single 1125-mg dose administered orally

Part A; Part B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (2)

Texas

Dallas, Texas, 75247, United States

Location

Wisconsin

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

US (2)