A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: TMC278 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s): Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
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 Japanese adult male participants.
Clinical Details
Official title: An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 After Oral Administration of TMC278 25 mg Tablet Under Fed Condition in Healthy Japanese Adult Male Subjects
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: plasma TMC278 concentrations
Secondary outcome: The number of participants who experience adverse events
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 consists of 3 phases: a screening phase up to 26 days; an inpatient phase from Day
- 2 to Day 8; and a follow-up assessment phase that occurs on Day 15 (± 2 days) or at the
time of the participant's early withdrawal from the study. Participants who meet the
selection criteria will be admitted to the investigational institute on two days before the
dose (Day - 2). All enrolled participants will receive orally (by mouth) a single dose of one
TMC278 25 mg tablet on Day 1 within 10 minutes after completion of the standardized
breakfast. Enrolled participants will remain in the investigational institute for the entire
duration of the inpatient phase. Participants will be discharged on Day 8 after the
completion of all required assessments. Blood samples for determination of plasma
concentrations of TMC278 will be collected over a period of 168 hours (7 days). The maximum
study duration for each participant is 45 days, including the screening phase, in-patient
period, and follow-up visit.
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Tokyo, Japan
Additional Information
An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 after Oral Administration of TMC278 25 mg Tablet under Fed Condition in Healthy Japanese Adult Male Subjects
Starting date: March 2013
Last updated: March 18, 2014
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