A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
NCT ID: NCT01511432
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2012-01-31
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Texas
Dallas, Texas, United States
Wisconsin
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VX11-950-025
Identifier Type: -
Identifier Source: org_study_id