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NCT01759875 · ClinicalTrials.gov registry record · Phase 1
Effects of Gastric pH on the Pharmacokinetics of Atazanavir
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01759875: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01759875 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759875, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Ritonavir-boosted Atazanavir
- DRUG Ritonavir-boosted Atazanavir plus Rabeprazole
- DRUG Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01759875 record still lists
NCT01759875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Ritonavir-boosted Atazanavir is the first listed.
NCT01759875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01759875 about?
NCT01759875 is a clinical study titled "Effects of Gastric pH on the Pharmacokinetics of Atazanavir". 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 i...
What is the current status of trial NCT01759875?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01759875?
The interventions under investigation include: Ritonavir-boosted Atazanavir (DRUG), Ritonavir-boosted Atazanavir plus Rabeprazole (DRUG), Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01759875?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01759875's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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