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Completed

NCT Number: NCT01511432

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Texas, Dallas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telaprevir formulation A

Drug

A single 1125-mg dose administered orally

telaprevir Formulation B

Drug

A single 1125-mg dose administered orally

telaprevir Formulation C

Drug

A single 1125-mg dose administered orally

telaprevir Formulation D

Drug

A single 1125-mg dose administered orally

Primary outcomes

  1. 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

  2. • 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

Secondary outcomes

  1. 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

  2. Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir

    Time frame: Up to 57 Days

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 18, 2012
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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