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Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)

NCT01181804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2017-04-07

Study results available
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Summary

This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions.

Conditions

  • Hepatitis C

Interventions

DRUG

boceprevir

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

DRUG

boceprevir

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

DRUG

boceprevir

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

DRUG

boceprevir

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181804 on ClinicalTrials.gov