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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult 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: NCT01631487
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE June 27, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date June 25, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Plasma concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 14 days ]
  • Urine concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 5 days ]
  • Plasma concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ]
  • Urine concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Plasma concentrations of JNJ-39439335 (Part 1) [ Time Frame: over 14 days ]
  • Urine concentrations of JNJ-39439335 (Part 1) [ Time Frame: over 5 days ]
  • Plasma concentrations of JNJ-39439335 (Part 2) [ Time Frame: over 21 days ]
  • Urine concentrations of JNJ-39439335 (Part 2) [ Time Frame: over 21 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • Incidence of Adverse Events (Part 1) [ Time Frame: Approximately 8 weeks ]
  • Incidence of Adverse Events (Part 2) [ Time Frame: Approximately 11 weeks ]
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 Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Sequential Group, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Subjects
Brief Summary The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.
Detailed Description This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: JNJ-39439335 10 mg
    Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
  • Drug: JNJ-39439335 25 mg
    Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
  • Drug: JNJ-39439335 50 mg
    Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.
  • Drug: Placebo
    Multiple (once daily for 21 days) oral doses of matching placebo.
Study Arms  ICMJE
  • Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 10 mg
    • Drug: Placebo
  • Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 25 mg
    • Drug: Placebo
  • Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 50 mg
    • Drug: Placebo
  • Experimental: Caucasian Group 1: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 10 mg
    • Drug: Placebo
  • Experimental: Caucasian Group 2: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 25 mg
    • Drug: Placebo
  • Experimental: Caucasian Group 3: JNJ-39439335/placebo (Part 1)
    Interventions:
    • Drug: JNJ-39439335 50 mg
    • Drug: Placebo
  • Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 2)
    Interventions:
    • Drug: JNJ-39439335 10 mg
    • Drug: Placebo
  • Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 2)
    Interventions:
    • Drug: JNJ-39439335 25 mg
    • Drug: Placebo
  • Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 2)
    Interventions:
    • Drug: JNJ-39439335 50 mg
    • Drug: Placebo
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: March 1, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
108
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese or Caucasian participants
  • Nonsmoker
  • Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
  • Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
  • Willing to adhere to the prohibitions and restrictions specified by the study protocol

Exclusion Criteria:

  • Oral temperatures > 37.5 Celsius degrees
  • Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
  • Abnormal electrocardiogram (ECG) results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631487
Other Study ID Numbers  ICMJE CR100890
39439335PAI1005 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date June 2013

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