TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435
A Phase I Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule and to Assess the Effect of Food on the Bioavailability of TMC435 Following Intake of the Phase IIb Capsule
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
The purpose of this study is to compare the levels of TMC435 in the blood circulation after intake of 2 tablet formulations with the level of TMC435 in the blood circulation after intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood circulation after intake of the capsule formulation fasted or following a meal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 17, 2010
May 1, 2010
3 months
November 25, 2009
May 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate and extent of absorption of TMC435 following administration of the tablet vs the capsule formulations and rate and extent of absorption of TMC435 following administration of the capsule formulation fasted or with food
Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (4) are 14 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken.
Secondary Outcomes (1)
Safety and tolerability following administration of single doses of 150 mg TMC435
AEs: continuously: laboratory, vital signs and ECG parameters: 3 visits per treatment, for 4 treatment periods
Interventions
Eligibility Criteria
You may qualify if:
- Non-smoker for at least 3 months
- Body Mass Index of 18.0 to 30.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
You may not qualify if:
- Infection with Hepatitis A, B or C virus
- Infection with the human immunodeficiency virus (HIV)
- Women who are pregnant or breastfeeding
- History of, or any current medical condition which could impact the safety of the participant in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 25, 2009
First Posted
December 1, 2009
Study Start
January 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 17, 2010
Record last verified: 2010-05