Status:
COMPLETED
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
Detailed Description
This is an open-label (all people know the identity of the intervention), single-center, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical trial) and ...
Eligibility Criteria
Inclusion
- Be a Japanese man aged 20 to 40 years, inclusive at the day of informed consent being signed
- Must agree to use an adequate contraception method (for example, double-barrier method) as deemed appropriate by the Investigators during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2) and body weight not less than 50 kilogram
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker or participant who has quitted any tobacco or nicotine containing products more than one year prior to screening
Exclusion
- History of or current clinically significant medical illness including (but not limited to), cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Use of any prescription or non-prescription medication (including vitamins and supplements) within 14 days before the administration on Day 1 of treatment Period 1
- History of drug or alcohol abuse within the past 5 years and positive test for drugs of abuse, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines or barbiturates and serum alcohol test
- Known allergy to the study drug or any of the excipients of the formulation
- Participated in another clinical study and received another study drugs administration or used an experimental medical device within 120 days or within a period less than 10 times the drug's half life, whichever is longer, before Day 1 of the first treatment period
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01799603
Start Date
May 1 2012
End Date
July 1 2012
Last Update
April 29 2013
Active Locations (1)
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1
Toshima City, Japan