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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00655746
First received: April 3, 2008
Last updated: December 8, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Dasatinib + Omeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose ] [ Designated as safety issue: No ]
  • Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax) [ Time Frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose ] [ Designated as safety issue: No ]
  • Dasatinib PK Parameter: Plasma Half-Life (T-HALF) [ Time Frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose ] [ Designated as safety issue: No ]
  • Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) [ Time Frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose ] [ Designated as safety issue: No ]
  • Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) [ Time Frame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations [ Time Frame: At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7) ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: April 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dasatinib + Omeprazole
Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
Other Name: Sprycel

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655746

Locations
United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00655746     History of Changes
Other Study ID Numbers: CA180-249
Study First Received: April 3, 2008
Results First Received: June 11, 2009
Last Updated: December 8, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Healthy Subjects

Additional relevant MeSH terms:
Dasatinib
Omeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014