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JAK Inhibitor

CTP-543 for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Concert Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose
Awards & highlights

Study Summary

This trial will study how different degrees of liver impairment affect the body's ability to process a new drug, CTP-543.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
Single dose PK exposure: Area Under the Concentration-Time Curve from time zero to the time of the last observed/measured non-zero concentration (AUC0-t)
Single dose PK exposure: Maximum observed concentration (Cmax)
Secondary outcome measures
Assessment of Safety and Tolerability following administration of CTP-543

Side effects data

From 2022 Phase 3 trial • 706 Patients • NCT04518995
12%
Headache
9%
Acne
6%
Blood creatine phosphokinase (increased)
5%
COVID-19
5%
Nasopharyngitis
3%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
CTP-543 8 mg BID
CTP-543 12 mg BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: CTP-543 Treatment - Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Group II: CTP-543 Treatment - Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTP-543
2021
Completed Phase 3
~2110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Concert PharmaceuticalsLead Sponsor
34 Previous Clinical Trials
4,390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
2022. "Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467722.
~7 spots leftby Apr 2025
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