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NCT01131091 · ClinicalTrials.gov registry record · Phase 1

A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

A Phase 1 study, sponsored by Kowa Research Institute.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01131091: Completed Phase 1 study, sponsored by Kowa Research Institute.

NCT01131091 is a Phase 1 study that has completed, run by Kowa Research Institute. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01131091, a Phase 1 study, has completed, sponsored by Kowa Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

Interventions

  • DRUG SK-0403

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-05
Est. Completion 2010-11
Phase Phase 1
Kowa Research Institute

44 total trials

What the finished NCT01131091 record still lists

NCT01131091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which SK-0403 is the first listed.

NCT01131091 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01131091 about?

NCT01131091 is a clinical study titled "A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403". This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

What is the current status of trial NCT01131091?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-05. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01131091?

The interventions under investigation include: SK-0403 (DRUG).

Who is sponsoring clinical trial NCT01131091?

This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01131091's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT01131091, the US trial registry maintained by the National Library of Medicine. NCT01131091 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.