Effects of Gastric pH on the Pharmacokinetics of Dasatinib

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Dasatinib plus Rabeprazole

Drug: Dasatinib

Drug: Dasatinib plus Rabeprazole AND Betaine Hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01398046

Dasatinib-63-03

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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