NCT01006304

Brief Summary

This exploratory study will use a thermal-grill experimental model to assess the effects of JNJ-39439335 (50 mg, single oral dose) on the relief of pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Jun 2009

Typical duration for phase_1 pain

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

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

First QC Date

October 29, 2009

Last Update Submit

July 1, 2010

Conditions

Pain

Keywords

JNJ-39439335PlaceboPainPain MeasurementsAdultsMen

Outcome Measures

Primary Outcomes (1)

  • The effects of JNJ-39439335 on the relief of paradoxical pain (the illusion of pain)

    at predose and at 4 hours postdose

Secondary Outcomes (2)

  • The effects of JNJ-39439335 on the non-painful cold and warm sensations corresponding respectively to the cold and warm temperatures used to induce paradoxical pain

    at predose and at 4 hours postdose in each of the 2 treatment periods

  • The effects of JNJ-39439335 on the normal cold- and heat-pain induced by supra-threshold cold and heat stimuli.

    at predose and at 4 hours postdose in each of the 2 treatment periods

Interventions

JNJ-39439335, PlaceboDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy man with body-mass-index of 18.5 to 30 kg/m2, inclusive

You may not qualify if:

  • Men who smoke or use tobacco within 3 months prior to the first study drug administration, and/or have a positive cotinine test result at Screening
  • and men who are not considered healthy based on the ECG, vital signs, physical examinations, and laboratory tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2009

First Posted

November 2, 2009

Study Start

June 1, 2009

Study Completion

June 1, 2010

Last Updated

July 2, 2010

Record last verified: 2010-07