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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511432
• Other study ID #: VX11-950-025
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: July 3, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• telaprevir formulation A
A single 1125-mg dose administered orally
• telaprevir Formulation B
A single 1125-mg dose administered orally
• telaprevir Formulation C
A single 1125-mg dose administered orally
• telaprevir Formulation D
A single 1125-mg dose administered orally

Locations

Country	Name	City	State
United States	Texas	Dallas	Texas
United States	Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-8)		Up to 57 days	No
Primary	• 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	No
Secondary	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	Yes
Secondary	Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir		Up to 57 Days	No