CTP-543 for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Orlando Clinical Research Center, Orlando, FL
Hepatic Impairment+1 More
CTP-543 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatic Impairment

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 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

Hour 48
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)
Day 21
Assessment of Safety and Tolerability following administration of CTP-543

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatic Impairment

Side Effects for

Cohort 1: CTP-543 4 mg BID
17%Headache
14%Cough
14%Acne
14%Nausea
10%Diarrhea
10%Oropharyngeal pain
10%Blood creatine phosphokinase increased
10%Nasopharyngitis
10%Folliculitis
7%Dermatitis contact
7%Abdominal pain
7%Upper respiratory tract infection
7%Body tinea
7%Viral upper respiratory tract infection
7%Aspartate aminotransferase increased
7%Vomiting
7%Fatigue
3%Dysgeusia
3%Sinus congestion
3%Hemoglobin decreased
3%Influenza
0%Sunburn
0%Pain in extremity
0%Dry eye
0%Thrombocytosis
0%Migraine
0%Amylase increased
0%Cellulitis
0%Hematocrit decreased
0%Sinusitis
0%Blood triglycerides increased
0%Rosacea
0%Low density lipoprotein increased
0%Anemia
0%Arthralgia
0%Gastroenteritis viral
0%Neutrophil count decreased
0%Depressed mood
0%Contusion
0%Red blood cell count decreased
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03137381) in the Cohort 1: CTP-543 4 mg BID ARM group. Side effects include: Headache with 17%, Cough with 14%, Acne with 14%, Nausea with 14%, Diarrhea with 10%.

Trial Design

2 Treatment Groups

CTP-543 Treatment - Mild Hepatic Impairment
1 of 2
CTP-543 Treatment - Moderate Hepatic Impairment
1 of 2
Experimental Treatment

22 Total Participants · 2 Treatment Groups

Primary Treatment: CTP-543 · No Placebo Group · Phase 1

CTP-543 Treatment - Mild Hepatic Impairment
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
CTP-543 Treatment - Moderate Hepatic Impairment
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTP-543
2022
Completed Phase 2
~410

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Orlando Clinical Research Center · Orlando, FL
Photo of Orlando 1Photo of Orlando 2Photo of Orlando 3
2004First Recorded Clinical Trial
47 TrialsResearching Hepatic Impairment
170 CompletedClinical Trials

Who is running the clinical trial?

Concert PharmaceuticalsLead Sponsor
34 Previous Clinical Trials
4,266 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are an adult male or female aged 18-75.
You have no clinically significant change in disease status within the last 30 days before screening.
You have diabetes and you have symptoms consistent with hepatic impairment
For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening.
You are of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.