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

NCT01732237 | Completed Phase 1

• 2 other identifiers: CR10087842396302EDI1003
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Healthy; JNJ-42396302; JNJ-42692507; JNJ-53773187; Pharmacokinetics

Outcome Measures

Primary Outcomes (12)

• Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours

Secondary Outcomes (1)

• Number of patients with adverse events

  within 7 days after the last dose of the study medication

Study Arms (3)

JNJ-42396302

EXPERIMENTAL

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

Drug: JNJ-42396302

JNJ-42692507

EXPERIMENTAL

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

Drug: JNJ-42692507

JNJ-53773187

EXPERIMENTAL

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

Drug: JNJ-53773187

Interventions

JNJ-42396302 DRUG

A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

JNJ-42396302

JNJ-42692507 DRUG

A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

JNJ-42692507

JNJ-53773187 DRUG

A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

JNJ-53773187

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 10, 2013

Record last verified: 2013-09