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NCT01883167 · ClinicalTrials.gov registry record · Phase 1
RDEA3170 and Febuxostat Drug Interaction Study
A Phase 1 study, sponsored by Ardea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01883167: Completed Phase 1 study, sponsored by Ardea Biosciences.
NCT01883167 is a Phase 1 study that has completed, run by Ardea Biosciences. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01883167, a Phase 1 study, has completed, sponsored by Ardea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.
Primary Outcome
Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance
Interventions
- DRUG placebo
- DRUG RDEA3170 10 mg
- DRUG Febuxostat 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01883167 record still lists
NCT01883167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01883167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01883167 about?
NCT01883167 is a clinical study titled "RDEA3170 and Febuxostat Drug Interaction Study". This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 dr...
What is the current status of trial NCT01883167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01883167?
The interventions under investigation include: placebo (DRUG), RDEA3170 10 mg (DRUG), Febuxostat 40 mg (DRUG).
Who is sponsoring clinical trial NCT01883167?
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 NCT01883167's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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