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Effects of Gastric pH on the Pharmacokinetics of Atazanavir

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ritonavir-boosted Atazanavir (Drug); Ritonavir-boosted Atazanavir plus Rabeprazole (Drug); Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of California, San Francisco

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).

Clinical Details

Official title: Effects of Gastric pH on the Pharmacokinetics of Atazanavir in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir

Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Atazanavir

Secondary outcome: Maximum Concentration of Atazanavir

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Clinical Research Center, UCSF, San Francisco, California 94143, United States
Additional Information

Starting date: January 2013
Last updated: April 24, 2015

Page last updated: August 23, 2015

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