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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 4

Conditions

Transplant Rejection

Treatments

Drug: Caffeine
Biological: Belatacept
Drug: Omeprazole
Drug: Dextromethorphan
Drug: Midazolam
Drug: Losartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766050
IM103-151

Details and patient eligibility

About

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

Enrollment

45 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Arm: Inje Cocktail + Belatacept
Experimental group
Description:
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
Treatment:
Drug: Losartan
Drug: Midazolam
Drug: Dextromethorphan
Biological: Belatacept
Drug: Omeprazole
Drug: Caffeine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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