Clinical Research Center, UCSF
San Francisco, California, 94143, United States
NCT Number: NCT01398046
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs).
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Notify Me18 year–59 year
All sexes
Interventional
Phase 1
San Francisco, California, 94143, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dasatinib (100mg) PO x1
Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4)
Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4
Time frame: Day 4
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Time frame: Day 4
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Time frame: Day 4
The maximum plasma concentration (Cmax) will also be measured. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Dasatinib alone) and tested for statistical significance.
University of California, San Francisco
Other
Effects of Gastric pH on the Pharmacokinetics of Dasatinib in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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