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

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ClinicalTrials.gov Identifier: NCT01732237
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: JNJ-42396302 Drug: JNJ-42692507 Drug: JNJ-53773187 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]

Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: within 7 days after the last dose of the study medication ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732237


Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
More Information
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01732237    
Other Study ID Numbers: CR100878
42396302EDI1003 ( Other Identifier: Janssen-Cilag International NV )
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013
Keywords provided by Janssen-Cilag International NV:
Healthy
JNJ-42396302
JNJ-42692507
JNJ-53773187
Pharmacokinetics