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Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

NCT ID: NCT01766050

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam

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Detailed Description

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Conditions

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Transplant Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm: Inje Cocktail + Belatacept

Inje Cocktail consisting of (200 mg Caffeine, 50 mg losartan tablet, 40 mg Omeprazole capsule, 30 mg Dextromethorphan capsule and 5 mg Midazolam oral syrup) administered on Days 1, 4, 7 and 11

Belatacept 10 mg/kg Intravenous (IV) solution, administered on Day 4

Group Type EXPERIMENTAL

Caffeine

Intervention Type DRUG

Losartan

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Dextromethorphan

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Belatacept

Intervention Type BIOLOGICAL

Interventions

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Caffeine

Intervention Type DRUG

Losartan

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Dextromethorphan

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Belatacept

Intervention Type BIOLOGICAL

Other Intervention Names

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Nulojix BMS-224818

Eligibility Criteria

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Inclusion Criteria

* BMI 18 to 30 kg/m2
* Men and women ages 18 to 45

Exclusion Criteria

* Active tuberculosis
* Any recent infection requiring antibiotic treatment within 4 weeks of dosing
* Positive urine screen for drugs of abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Healthcare Discoveries, Llc D/B/A Icon Development Solutions

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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IM103-151

Identifier Type: -

Identifier Source: org_study_id

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