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 |
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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