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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Transplant Rejection

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

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)

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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: Omeprazole

Drug: Caffeine

Drug: Dextromethorphan

Drug: Losartan

Drug: Midazolam

Biological: Belatacept