Effects of Gastric pH on the Pharmacokinetics of Dasatinib

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dasatinib

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

dasatinib (100mg) PO x1

Dasatinib plus Rabeprazole

Group Type EXPERIMENTAL

Dasatinib plus Rabeprazole

Intervention Type DRUG

Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4)

Dasatinib plus Rabeprazole AND Betaine Hydrochloride

Group Type EXPERIMENTAL

Dasatinib plus Rabeprazole AND Betaine Hydrochloride

Intervention Type DRUG

Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4

Interventions

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Dasatinib

dasatinib (100mg) PO x1

Intervention Type DRUG

Dasatinib plus Rabeprazole

Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4)

Intervention Type DRUG

Dasatinib plus Rabeprazole AND Betaine Hydrochloride

Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes