Effects of Gastric pH on the Pharmacokinetics of Atazanavir

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ritonavir-boosted Atazanavir; Drug: Ritonavir-boosted Atazanavir plus Rabeprazole; Drug: Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride

• Registration Number: NCT01759875
• Lead Sponsor: University of California, San Francisco

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-30
• Study First Submitted QC: 2012-12-30
• Study Start: 2013-01
• Study First Posted: 2013-01-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ritonavir-boosted Atazanavir	Ritonavir-boosted Atazanavir	-
Ritonavir-boosted Atazanavir plus Rabeprazole	Ritonavir-boosted Atazanavir plus Rabeprazole	-
Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine HCl	Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir	Day 4	The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted atazanavir alone) and tested for statistical significance.
Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Atazanavir	Day 4	The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance.

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration of Atazanavir	Day 4	The maximum plasma concentration (Cmax) will also be measured. Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance.

Trial Locations

Locations (1)

Clinical Research Center, UCSF; 🇺🇸 San Francisco, California, United States