The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dasatinib + Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655746

CA180-249

Details and patient eligibility

About

The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects as determined by medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion criteria

• Women who are pregnant or breastfeeding
• Prior exposure to dasatinib

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Dasatinib + Omeprazole