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NCT05468749 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543

A Phase 1 study, sponsored by Concert Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT05468749: Completed Phase 1 study, sponsored by Concert Pharmaceuticals.

NCT05468749 is a Phase 1 study that has completed, run by Concert Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05468749, a Phase 1 study, has completed, sponsored by Concert Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.

Primary Outcome

Maximum concentration, obtained directly from the observed concentration versus time data.

Interventions

  • DRUG CTP-543

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2022-06-06
Est. Completion 2022-10-27
Phase Phase 1
Concert Pharmaceuticals

24 total trials

What the finished NCT05468749 record still lists

NCT05468749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which CTP-543 is the first listed.

NCT05468749 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05468749 about?

NCT05468749 is a clinical study titled "Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543". This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.

What is the current status of trial NCT05468749?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-06-06. Estimated completion is 2022-10-27.

What interventions are being tested in trial NCT05468749?

The interventions under investigation include: CTP-543 (DRUG).

Who is sponsoring clinical trial NCT05468749?

This trial is sponsored by Concert Pharmaceuticals, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05468749's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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 NCT05468749, the US trial registry maintained by the National Library of Medicine. NCT05468749 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.