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NCT01074710 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers
A Phase 1 study of Gastroparesis, sponsored by Otsuka Pharmaceutical Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01074710: Completed Phase 1 study of Gastroparesis, sponsored by Otsuka Pharmaceutical Co..
NCT01074710 is a Phase 1 study of Gastroparesis that has completed, run by Otsuka Pharmaceutical Co.. The registered enrollment target is 8 participants, below the 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01074710, a Phase 1 study of Gastroparesis, has completed, sponsored by Otsuka Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers
Primary Outcome
Pharmacokinetic endpoints will include apparent clearance (CL/F), AUCt, AUC∞, Cmax, tmax, and t1/2,Z for 13C-uracil and its metabolites. The PK linearity and correlation between plasma concentration and urine excretion will be evaluated. Expired 13CO2 concentrations (Δ13C) will be converted to 13CO2-excretion(% dose/hr) to assess breath PK parameters (AUCt, AUC∞, Cmax, tmax, λZ, and t1/2,Z).
Conditions Studied
Interventions
- DRUG [2-13C] uracil
- DRUG [2-13C] uracil, placebo
Study Locations (1)
Wisconsin
- Covance Clinical Pharmacology, Inc. - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT01074710 record still lists
NCT01074710 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 302-participant average among 44 other Gastroparesis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which [2-13C] uracil is the first listed.
NCT01074710 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01074710 about?
NCT01074710 is a clinical study titled "Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers". The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers
What is the current status of trial NCT01074710?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2010-02. Estimated completion is 2010-05.
What conditions does trial NCT01074710 study?
This clinical trial studies the following conditions: Gastroparesis.
What interventions are being tested in trial NCT01074710?
The interventions under investigation include: [2-13C] uracil (DRUG), [2-13C] uracil, placebo (DRUG).
Who is sponsoring clinical trial NCT01074710?
This trial is sponsored by Otsuka Pharmaceutical Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01074710 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01074710's enrollment target sits among peer trials
8 44th of 44 higher than 1 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis 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.
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