Phase 1
Completed N=14
The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT00655746 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) — 65.58; 38.64 ng/mL
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) |
65.58; 38.64 | — |
| PRIMARY Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax) |
0.75; 1.00 | — |
| PRIMARY Dasatinib PK Parameter: Plasma Half-Life (T-HALF) |
4.00; 4.29 | — |
| PRIMARY Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) |
249.46; 137.49 | — |
| PRIMARY Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) |
265.40; 152.84 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations |
3; 2; 2; 4; 0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00655746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.