NCT01631487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

June 27, 2012

Last Update Submit

June 24, 2013

Conditions

Healthy

Keywords

HealthyJNJ-39439335JapaneseCaucasianMale

Outcome Measures

Primary Outcomes (4)

  • Plasma concentrations of JNJ-39439335 (Part 1)

    up to 14 days

  • Urine concentrations of JNJ-39439335 (Part 1)

    up to 5 days

  • Plasma concentrations of JNJ-39439335 (Part 2)

    up to 21 days

  • Urine concentrations of JNJ-39439335 (Part 2)

    up to 21 days

Secondary Outcomes (2)

  • Incidence of Adverse Events (Part 1)

    Approximately 8 weeks

  • Incidence of Adverse Events (Part 2)

    Approximately 11 weeks

Study Arms (9)

Japanese Group 1: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 10 mgDrug: Placebo

Japanese Group 2: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 25 mgDrug: Placebo

Japanese Group 3: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 50 mgDrug: Placebo

Caucasian Group 1: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 10 mgDrug: Placebo

Caucasian Group 2: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 25 mgDrug: Placebo

Caucasian Group 3: JNJ-39439335/placebo (Part 1)

EXPERIMENTAL
Drug: JNJ-39439335 50 mgDrug: Placebo

Japanese Group 1: JNJ-39439335/placebo (Part 2)

EXPERIMENTAL
Drug: JNJ-39439335 10 mgDrug: Placebo

Japanese Group 2: JNJ-39439335/placebo (Part 2)

EXPERIMENTAL
Drug: JNJ-39439335 25 mgDrug: Placebo

Japanese Group 3: JNJ-39439335/placebo (Part 2)

EXPERIMENTAL
Drug: JNJ-39439335 50 mgDrug: Placebo

Interventions

JNJ-39439335 10 mgDRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.

Caucasian Group 1: JNJ-39439335/placebo (Part 1)Japanese Group 1: JNJ-39439335/placebo (Part 1)Japanese Group 1: JNJ-39439335/placebo (Part 2)
JNJ-39439335 25 mgDRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.

Caucasian Group 2: JNJ-39439335/placebo (Part 1)Japanese Group 2: JNJ-39439335/placebo (Part 1)Japanese Group 2: JNJ-39439335/placebo (Part 2)
JNJ-39439335 50 mgDRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

Caucasian Group 3: JNJ-39439335/placebo (Part 1)Japanese Group 3: JNJ-39439335/placebo (Part 1)Japanese Group 3: JNJ-39439335/placebo (Part 2)
PlaceboDRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Caucasian Group 1: JNJ-39439335/placebo (Part 1)Caucasian Group 2: JNJ-39439335/placebo (Part 1)Caucasian Group 3: JNJ-39439335/placebo (Part 1)Japanese Group 1: JNJ-39439335/placebo (Part 1)Japanese Group 1: JNJ-39439335/placebo (Part 2)Japanese Group 2: JNJ-39439335/placebo (Part 1)Japanese Group 2: JNJ-39439335/placebo (Part 2)Japanese Group 3: JNJ-39439335/placebo (Part 1)Japanese Group 3: JNJ-39439335/placebo (Part 2)

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

June 29, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)