Status:
COMPLETED
A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 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 safety, tolerability, and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in healthy male pa...
Detailed Description
This is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive subs...
Eligibility Criteria
Inclusion
- Male participant, aged 18 to 55 inclusive
- Participant must have a body Mass Index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive, and body weight not less than 50 kg
- Participant must be deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
- Participant agrees to protocol-defined use of effective contraception
- Participant should be non-nicotine user for 6 months prior to screening
Exclusion
- Participants with current or history of clinically significant medical illness
- Participants with history of drug or alcohol abuse within 5 years
- Routine consumption of greater than 450 milligram (mg) of caffeine per day by the participant
- Participants with recent vaccination or acute illness
- Blood donation or major blood loss within 3 months prior to study drug administration by the participant
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02280018
Start Date
November 1 2014
End Date
December 1 2014
Last Update
January 30 2015
Active Locations (1)
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1
Merksem, Belgium