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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655746
First Posted: April 10, 2008
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00655746     History of Changes
Other Study ID Numbers: CA180-249
First Submitted: April 3, 2008
First Posted: April 10, 2008
Results First Submitted: June 11, 2009
Results First Posted: July 31, 2009
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Bristol-Myers Squibb:
Healthy Subjects

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