A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804244
• Other study ID #: CR101181
• Secondary ID: TMC278IFD4005
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2013
• Last updated: March 18, 2014
• Start date: March 2013
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TMC278
1 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma TMC278 concentrations	Blood samples will be taken at 16 timepoints: Predose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, and 168 hours postdose.	Baseline (predose) up to 168 hours postdose	No
Secondary	The number of participants who experience adverse events	As a measure of safety and tolerability	Up to 17 days following study drug administration	No

External Links

•   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