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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
Number of patients with adverse events [ Time Frame: within 7 days after the last dose of the study medication ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants
Official Title  ICMJE A Single Dose Study to Investigate the Pharmacokinetics of an Oral Microdose of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Subjects
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: JNJ-42396302
    A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
  • Drug: JNJ-42692507
    A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
  • Drug: JNJ-53773187
    A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
Study Arms  ICMJE
  • Experimental: JNJ-42396302
    Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
    Intervention: Drug: JNJ-42396302
  • Experimental: JNJ-42692507
    Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
    Intervention: Drug: JNJ-42692507
  • Experimental: JNJ-53773187
    Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
    Intervention: Drug: JNJ-53773187
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2012)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732237
Other Study ID Numbers  ICMJE CR100878
42396302EDI1003 ( Other Identifier: Janssen-Cilag International NV )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag International NV
Study Sponsor  ICMJE Janssen-Cilag International NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP