A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-53773187; Drug: JNJ-42396302; Drug: JNJ-42692507

Study type: Interventional

Funder types: Industry

Identifiers

NCT01732237

CR100878

42396302EDI1003 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants.

Full description

This is a phase I, open-label (all people know the identity of the intervention) and parallel-group (each group of patients will be treated at the same time), randomized (the study medication is assigned by chance) study in healthy male participants, to investigate the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first dose of study medication), a treatment phase, and a follow up phase. In the treatment phase, participants will be divided into 3 treatment groups with 6 participants each, to receive a single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be approximately 4 weeks.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant should be healthy male on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis
• Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
• Have a blood pressure between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
• Agrees to protocol-defined use of effective contraception

Exclusion criteria

• A positive human immunodeficiency virus-type 1 or type 2 test and Hepatitis A, B or C infection at screening or admission
• Participant with abnormal physical, vital or laboratory values
• Currently active cardiovascular, bronchospastic respiratory disease, dyspnea, diabetes mellitus, movement disorder and infectious disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

JNJ-42396302

Experimental group

Description:

Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Treatment:

Drug: JNJ-42396302

JNJ-42692507

Experimental group

Description:

Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Treatment:

Drug: JNJ-42692507

JNJ-53773187

Experimental group

Description:

Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Treatment:

Drug: JNJ-53773187