Status:
COMPLETED
A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy J...
Detailed Description
This is a single center, open-label (all study staff and participants will know the identity of the treatment assigned), single dose study in healthy Japanese adult male participants. The study consis...
Eligibility Criteria
Inclusion
- Japanese healthy men
- body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive and a body weight of not less than 50 kg
Exclusion
- History of or current medical illness considered by the investigator to be clinically significant and should exclude the participant or that could interfere with the interpretation of the study results
- Laboratory abnormality of grade 2 or greater (defined by the World Health Organization Adult Toxicity Table) or clinically significant abnormal values as assessed by the investigators
- Clinically significant abnormal physical examination and vital signs at screening as assessed by the investigators
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), within 14 days before the dose of TMC278 25 mg tablet
- History of clinically significant drug or food allergies, especially known hypersensitivity and/or known allergy to TMC278 or any of the excipients of the formulation
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01804244
Start Date
March 1 2013
End Date
March 1 2013
Last Update
March 19 2014
Active Locations (1)
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1
Tokyo, Japan