Effects of Gastric pH on the Pharmacokinetics of Atazanavir

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Atazanavir Sulfate; Betaine; Rabeprazole; Ritonavir

Criteria

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