Status:
COMPLETED
Effects of Gastric pH on the Pharmacokinetics of Dasatinib
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
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 hy...
Eligibility Criteria
Inclusion
- Male or female 18-59 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
- BMI between 18.5-30 kg/m2
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- Be able to provide written informed consent and comply with requirements of the study
- Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until the completion of the entire study
- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
- Fast from food and beverages at least 8 hours prior to medication dosing
- Be able to read, speak, and understand English
Exclusion
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
- Subjects with a fasting gastric pH of \> 4 (i.e. hypochlorhydria)
- Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
- Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
- Subjects with known allergies to rabeprazole or any other proton pump inhibitors (PPI's) or betaine hydrochloride
- Subjects who smoke tobacco
- Subjects with ongoing alcohol or illegal drug use
- Subjects who are pregnant, lactating, or attempting to conceive
- Subjects unable to maintain adequate birth control during the study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01398046
Start Date
August 1 2011
End Date
February 1 2014
Last Update
April 28 2015
Active Locations (1)
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1
Clinical Research Center, UCSF
San Francisco, California, United States, 94143