TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers
Phase I, Open Label, Randomized Study to Examine the Pharmacokinetics, Safety and Tolerability of Different Oral Doses of TMC435 After Single and Repeated Dosing in Healthy Chinese Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMay 8, 2014
May 1, 2014
3 months
October 18, 2010
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
plasma concentration of TMC435 after a single oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
measured on Day 1, 2, 3
plasma concentration of TMC435 after a multiple oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
measured on Day 4 until 11
Secondary Outcomes (2)
Safety and tolerability of TMC435 after single oral dose of 100 and 200 mg in healthy Chinese volunteers
Day 1 until Day 3
Safety and tolerability of TMC435 after multiple oral dose of 100 and 200 mg q.d. for 5 days in healthy Chinese volunteers
Day 4 until Day 11 and 12 to 15 days and 38 to 43 days after last intake as safety follow up
Study Arms (2)
001
EXPERIMENTALTMC435 100 or 200 mg capsule one single dose
002
EXPERIMENTALTMC435 100 or 200 mg capsule once daily for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months.
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
Study Sites (1)
Unknown Facility
Shatin, Hong Kong
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 8, 2014
Record last verified: 2014-05