Effects of Gastric pH on the Pharmacokinetics of Dasatinib
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 10/19/2013 |
| Start Date: | August 2011 |
| End Date: | June 2013 |
| Contact: | Marc R Yago, B.S. |
| Email: | marcanthony.yago@ucsf.edu |
| Phone: | 415-476-5890 |
Effects of Gastric pH on the Pharmacokinetics of Dasatinib in Healthy Volunteers
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).
Inclusion Criteria:
- 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 Criteria:
- 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
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