Status:
COMPLETED
A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4 inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a drug enters and leaves...
Detailed Description
This is a single-center, open-label (participants and researchers are aware about the treatment, participants are receiving), fixed-sequence study in healthy male participants consisting of 2 sequenti...
Eligibility Criteria
Inclusion
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study, and are willing to participate in the study
- Body mass index between 18 and 30 kilogram per square meter
- Must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or admission (up to Day 1 predose)
- Man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must also agree to not donate sperm during the study and for 90 days after receiving the study drug
- Participant must be healthy on the basis of clinical laboratory tests performed at Screening and/or admission and as per investigator's judgment
Exclusion
- History of or current liver or renal impairment, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, dermatological or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients, itraconazole (Part 1 only) or clarithromycin (Part 2 only)
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
- History of drug or alcohol abuse within 6 months before Screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, benzodiazepines and cotinine) at Screening or admission
- Smoking of cigarettes (or equivalent) and/or used nicotine based products within 3 months prior to study drug administration
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02197884
Start Date
July 1 2014
End Date
September 1 2014
Last Update
October 15 2014
Active Locations (1)
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1
Merksem, Belgium