A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-49122944, 5 milligram (mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280018

CR105925

2014-002354-39 (EudraCT Number)

49122944EDI1001 (Other Identifier)

Details and patient eligibility

About

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 participants after a single intravenous ([IV] within a vein) dose administration.

Full 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 substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), and single-center study. The study will consist of Screening Period (2 to 21 days prior to participants' dose administration), Double-blind Treatment Period (single dose of JNJ-49122944 or placebo on Day 1), and Safety Follow-up Period (4 to 7 days after discharge). The total duration of participation for each participant, including screening, will be up to approximately 4 weeks. Blood samples will be collected for assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

JNJ-49122944, 5 milligram (mg)

Experimental group

Description:

Single dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast.

Treatment:

Drug: JNJ-49122944, 5 milligram (mg)

Placebo

Placebo Comparator group

Description:

Placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast.

Treatment:

Drug: Placebo