Effects of Gastric pH on the Pharmacokinetics of Atazanavir



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:10/3/2013
Start Date:January 2013
End Date:January 2014
Contact:Kathleen P Faber, B.S.
Email:kate.faber@ucsf.edu
Phone:415-502-6717

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Effects of Gastric pH on the Pharmacokinetics of Atazanavir in Healthy Volunteers


The goal of this study is to evaluate the ability of a natural supplement (betaine
hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The
investigators predict that betaine hydrochloride will increase the absorption of atazanavir
in volunteers pre-treated with proton-pump inhibitors (PPIs).


Inclusion Criteria:

- Male or female 18-65 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 rabeprazole, 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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