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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: JNJ-42396302 Drug: JNJ-42692507 Drug: JNJ-53773187	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose Study to Investigate the Pharmacokinetics of an Oral Microdose of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Subjects

Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:

Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration time curve for JNJ-42396302 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Apparent terminal elimination half-life of JNJ-42396302 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration time curve for JNJ-53773187 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Apparent terminal elimination half-life of JNJ-53773187 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration time curve for JNJ-42692507 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]
Apparent terminal elimination half-life of JNJ-42692507 [ Time Frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients with adverse events [ Time Frame: within 7 days after the last dose of the study medication ] [ Designated as safety issue: Yes ]


Enrollment:	18
Study Start Date:	August 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: JNJ-42396302 Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.	Drug: JNJ-42396302 A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
Experimental: JNJ-42692507 Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.	Drug: JNJ-42692507 A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
Experimental: JNJ-53773187 Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.	Drug: JNJ-53773187 A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732237

Sponsors and Collaborators

Janssen-Cilag International NV

Investigators


Study Director:	Janssen-Cilag International NV Clinical Trial	Janssen-Cilag International NV

More Information


Responsible Party:	Janssen-Cilag International NV
ClinicalTrials.gov Identifier:	NCT01732237 History of Changes
Other Study ID Numbers:	CR100878 42396302EDI1003
Study First Received:	November 19, 2012
Last Updated:	September 9, 2013
Health Authority:	Belgium: Federal Agency for Drugs and Health products

Keywords provided by Janssen-Cilag International NV:


Healthy JNJ-42396302 JNJ-42692507 JNJ-53773187 Pharmacokinetics

ClinicalTrials.gov processed this record on September 30, 2016