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NCT01432561 · ClinicalTrials.gov registry record · NA
Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01432561: Completed NA study, sponsored by University of California, San Diego.
NCT01432561 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01432561, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.
Primary Outcome
Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II \& III visits.
Interventions
- DRUG Cysteamine bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01432561 record still lists
NCT01432561 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Cysteamine bitartrate is the first listed.
NCT01432561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01432561 about?
NCT01432561 is a clinical study titled "Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™". In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collec...
What is the current status of trial NCT01432561?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2011-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01432561?
The interventions under investigation include: Cysteamine bitartrate (DRUG).
Who is sponsoring clinical trial NCT01432561?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01432561's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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