NCT05468749 is a Phase 1 clinical trial of CTP-543 in Renal Impairment, sponsored by Concert Pharmaceuticals.

Who is sponsoring NCT05468749?

NCT05468749 is sponsored by Concert Pharmaceuticals.

What drugs are being tested in NCT05468749?

Interventions in NCT05468749: CTP-543.

What condition does NCT05468749 study?

NCT05468749 studies Renal Impairment.

Is NCT05468749 still recruiting?

NCT05468749 is currently completed. Last updated 29 November 2022.

Last reviewed 2022-11-29 · How we verify

NCT05468749

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 29 November 2022

What this trial tests

Phase 1 trial testing CTP-543 in Renal Impairment in 16 participants. Completed in 27 October 2022.

Timeline

6 June 2022

Primary endpoint
20 October 2022

27 October 2022

Quick facts

Lead sponsor	Concert Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	16
Start date	6 June 2022
Primary completion	20 October 2022
Estimated completion	27 October 2022
Sites	2 locations across United States

Drugs / interventions tested

CTP-543 — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →

Sponsor

Concert Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Deuterium in drug discovery: progress, opportunities and challenges.
Di Martino RMC, Maxwell BD, Pirali T. · · 2023 · cited 228× · PMID 37277503 · DOI 10.1038/s41573-023-00703-8

Verify or expand the search:

Other trials of CTP-543

Trials testing the same drug.

NCT05478772 — Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in He · Phase 1 · completed
NCT05467709 — Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Health · Phase 1 · completed
NCT05467696 — Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers · Phase 1 · completed
NCT05467722 — Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
NCT05192369 — A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers · Phase 1 · completed

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting

Other Concert Pharmaceuticals trials

Trials by the same sponsor.

NCT05478772 — Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in He · Phase 1 · completed
NCT05467709 — Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Health · Phase 1 · completed
NCT05467696 — Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers · Phase 1 · completed
NCT05467722 — Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 · Phase 1 · completed
NCT05192369 — A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05468749 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Concert Pharmaceuticals
Last refreshed: 29 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05468749.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing