Effects of Gastric pH on the Pharmacokinetics of Atazanavir
NCT ID: NCT01759875
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2013-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Ritonavir-boosted Atazanavir
Ritonavir-boosted Atazanavir
Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1
Ritonavir-boosted Atazanavir plus Rabeprazole
Ritonavir-boosted Atazanavir plus Rabeprazole
Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4)
Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine HCl
Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride
Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4
Interventions
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Ritonavir-boosted Atazanavir
Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1
Ritonavir-boosted Atazanavir plus Rabeprazole
Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4)
Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride
Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Locations
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Clinical Research Center, UCSF
San Francisco, California, United States
Countries
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Other Identifiers
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CRS6537
Identifier Type: -
Identifier Source: org_study_id
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