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NCT01986556 · ClinicalTrials.gov registry record · Phase 1

Lesinurad Tablet Relative Bioavailability

A Phase 1 study, sponsored by Ardea Biosciences.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT01986556: Completed Phase 1 study, sponsored by Ardea Biosciences.

NCT01986556 is a Phase 1 study that has completed, run by Ardea Biosciences. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01986556, a Phase 1 study, has completed, sponsored by Ardea Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

Primary Outcome

PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); and apparent terminal half-life (t1/2).

Interventions

  • DRUG Lesinurad 400 mg (Site 1)
  • DRUG Lesinurad 400 mg (Site 2, Lot A)
  • DRUG Lesinurad 400 mg (Site 2, Lot B)

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2013-11
Est. Completion 2014-05
Phase Phase 1
Ardea Biosciences

32 total trials

What the finished NCT01986556 record still lists

NCT01986556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which Lesinurad 400 mg (Site 1) is the first listed.

NCT01986556 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01986556 about?

NCT01986556 is a clinical study titled "Lesinurad Tablet Relative Bioavailability". This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.

What is the current status of trial NCT01986556?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-11. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01986556?

The interventions under investigation include: Lesinurad 400 mg (Site 1) (DRUG), Lesinurad 400 mg (Site 2, Lot A) (DRUG), Lesinurad 400 mg (Site 2, Lot B) (DRUG).

Who is sponsoring clinical trial NCT01986556?

This trial is sponsored by Ardea Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01986556's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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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Source: ClinicalTrials.gov NCT01986556, the US trial registry maintained by the National Library of Medicine. NCT01986556 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.