Expired Study
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Hamilton, New Jersey 08690


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


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


Study is Available At:


Original ID:

CA180-249


NCT ID:

NCT00655746


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Study Dates

Start Date:April 2008
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:May 2008
Primary Completion Type:Actual
Verification Date:December 2009
Last Changed Date:December 8, 2009
First Received Date:April 3, 2008
First Results Date:June 11, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Dasatinib + Omeprazole
Description:Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
Arm Name:1
Other Name:Sprycel

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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