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
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: JNJ-42396302 Drug: JNJ-42692507 Drug: JNJ-53773187 | Phase 1 |
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 |
Arm | Intervention/treatment |
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Experimental: JNJ-42396302
Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
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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.
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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.
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Drug: JNJ-53773187
A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Number of patients with adverse events [ Time Frame: within 7 days after the last dose of the study medication ]

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

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
Study Director: | Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV |
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 |
Healthy JNJ-42396302 JNJ-42692507 JNJ-53773187 Pharmacokinetics |