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NCT01398046 · ClinicalTrials.gov registry record · Phase 1
Effects of Gastric pH on the Pharmacokinetics of Dasatinib
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01398046: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01398046 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01398046, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 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 dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump inhibitors (PPIs).
Primary Outcome
The primary outcome measure will be dasatinib area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experiemntal Arms of the study (Dasatinib plus Rabeprazole; Dasatinib plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (dasatinib alone) and tested for statistical significance.
Interventions
- DRUG Dasatinib
- DRUG Dasatinib plus Rabeprazole
- DRUG Dasatinib plus Rabeprazole AND Betaine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01398046 record still lists
NCT01398046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Dasatinib is the first listed.
NCT01398046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01398046 about?
NCT01398046 is a clinical study titled "Effects of Gastric pH on the Pharmacokinetics of Dasatinib". The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of dasatinib in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of dasatinib, in volunteers pre-treated with proton-pump in...
What is the current status of trial NCT01398046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-08. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01398046?
The interventions under investigation include: Dasatinib (DRUG), Dasatinib plus Rabeprazole (DRUG), Dasatinib plus Rabeprazole AND Betaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01398046?
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 NCT01398046's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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