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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01511432
First received: January 9, 2012
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: telaprevir formulation A
Drug: telaprevir Formulation B
Drug: telaprevir Formulation C
Drug: telaprevir Formulation D
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞) [ Time Frame: Up to 57 days ] [ Designated as safety issue: No ]
  • • PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast) [ Time Frame: Up to 57 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 57days ] [ Designated as safety issue: Yes ]
  • Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir [ Time Frame: Up to 57 Days ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511432

Locations
United States, Texas
Texas
Dallas, Texas, United States, 75247
United States, Wisconsin
Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01511432     History of Changes
Other Study ID Numbers: VX11-950-025
Study First Received: January 9, 2012
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
Relative bioavailability
telaprevir formulations

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014