A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01631487
First received: June 27, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: JNJ-39439335 10 mg
Drug: JNJ-39439335 25 mg
Drug: JNJ-39439335 50 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Plasma concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
  • Urine concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Plasma concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Urine concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Adverse Events (Part 1) [ Time Frame: Approximately 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (Part 2) [ Time Frame: Approximately 11 weeks ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 1) Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 1) Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 1) 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.
Experimental: Caucasian Group 1: JNJ-39439335/placebo (Part 1) Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Caucasian Group 2: JNJ-39439335/placebo (Part 1) Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Caucasian Group 3: JNJ-39439335/placebo (Part 1) 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.
Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 2) Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 2) Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 2) 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631487

Locations
United States, California
Cypress, California, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01631487     History of Changes
Other Study ID Numbers: CR100890, 39439335PAI1005
Study First Received: June 27, 2012
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-39439335
Japanese
Caucasian
Male

ClinicalTrials.gov processed this record on July 29, 2014