NCT01258777

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2010

Typical duration for phase_1 healthy-volunteers

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

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

First QC Date

November 22, 2010

Last Update Submit

September 3, 2013

Conditions

Healthy Volunteers

Keywords

Healthy volunteersJapanese maleCaucasian maleSimponi

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects

    Week 12 (Day 78)

  • Determine the immune response of golimumab in Japanese and Caucasian Male subjects

    Week 12 (Day 78)

  • Safety of golimumab in Japanese and Caucasian Male subjects

    Week 12 (Day 78)

  • Tolerability of golimumab in Japanese and Caucasian Male subjects

    Week 12 (Day 78)

Study Arms (2)

001

EXPERIMENTAL

200 mg golimumab or placebo Single dose of 200 mg subcutaneously

Drug: 200 mg golimumab or placebo

002

EXPERIMENTAL

400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Drug: 400 mg golimumab or placebo

Interventions

400 mg golimumab or placeboDRUG

Single dose of 400 mg subcutaneously

002
200 mg golimumab or placeboDRUG

Single dose of 200 mg subcutaneously

001

Eligibility Criteria

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

You may qualify if:

  • Have no clinically relevant abnormalities
  • non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
  • Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
  • Japanese subjects must have a valid Japanese passport
  • Caucasian subjects must have Caucasian parents.

You may not qualify if:

  • Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Have any underlying physical or psychological medical condition
  • Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

golimumab

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 22, 2010

First Posted

December 13, 2010

Study Start

October 1, 2010

Study Completion

April 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

US(1)