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NCT01910506 · ClinicalTrials.gov registry record · Phase 1
RDEA3170 AME Study
A Phase 1 study, sponsored by Ardea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01910506: Completed Phase 1 study, sponsored by Ardea Biosciences.
NCT01910506 is a Phase 1 study that has completed, run by Ardea Biosciences. 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
NCT01910506, a Phase 1 study, has completed, sponsored by Ardea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]RDEA3170 in healthy adult male subjects.
Primary Outcome
PK profile in terms of AUC, Tmax, Cmax, t1/2, Ae, CLr, and CL/F. AUC: area under the concentration-time curve; Tmax: time to reach maximum concentration; Cmax: maximum concentration; t1/2: apparent terminal half-life; Ae: amount of compound excreted in urine unchanged; CLr: renal clearance; CL/F: total body clearance corrected for bioavailability Metabolic profile of RDEA3170 in plasma, urine, and feces. Excretion in terms of recovery of radioactivity in urine and feces.
Interventions
- DRUG RDEA3170 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01910506 record still lists
NCT01910506 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 1 intervention - of which RDEA3170 10 mg is the first listed.
NCT01910506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01910506 about?
NCT01910506 is a clinical study titled "RDEA3170 AME Study". This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]RDEA3170 in healthy adult male subjects.
What is the current status of trial NCT01910506?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01910506?
The interventions under investigation include: RDEA3170 10 mg (DRUG).
Who is sponsoring clinical trial NCT01910506?
This trial is sponsored by Ardea Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01910506'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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