Status:
COMPLETED
Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg)...
Detailed Description
This is a randomized (study drug assigned by chance), open-label (all people know the identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study of oral JNJ-42756493...
Eligibility Criteria
Inclusion
- Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered an opportunity to participate by signing the separate pharmacogenomic informed consent document
- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or surgically sterile
- If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
- Body mass index (BMI) (weight kilogram \[kg\]/ height square meter\[m\^2\] between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kg
- Non-smoker for at least 6 months before entering the study
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, metabolic bone disease (other than osteoporosis), infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening and predose on Day -2 (urinalysis only) and on Day -1 of both treatment Period as deemed appropriate by the investigator. Retesting of abnormal lab values that may lead to exclusion will be allowed once
- Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02218073
Start Date
October 1 2014
End Date
December 1 2014
Last Update
January 8 2015
Active Locations (1)
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1
Merksem, Belgium