Hepatic ImpairmentPhase 1NCT05467722
Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
A Phase 1 study testing CTP-543 in people with Hepatic Impairment, run by Concert Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- CTP-543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2022to 21 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or females aged 18-75
- Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
- If 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
- Capable of giving informed consent and complying with study procedures
- Additional Inclusion Criteria for Subjects with Hepatic Impairment:
- For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening.
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- No clinically significant change in disease status within the last 30 days before screening
- The subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the Investigator
- If diabetic, the subject must have the disease controlled
Who cannot join
- History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Known history of any GI surgery or any condition possibly affecting drug absorption
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 470 msec for males or QTcF > 480 msec for females at Screening visit.
- Females who are nursing or pregnant prior to drug administration
- Positive for human immunodeficiency virus (HIV)
- Positive results for coronavirus infection (COVID-19) at screening or check-in
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- Positive drugs of abuse or alcohol results at screening or check in (Day -1)
- Additional Exclusion Criteria for Subjects with Hepatic Impairment:
- History or current diagnosis of uncontrolled or significant cardiac disease
- Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening
- Previous diagnosis of hepatocellular carcinoma
- Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)
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.
- Conditions
- Hepatic Impairment
- Being tested
- CTP-543
- Keywords
- CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
Single 12 mg oral dose administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| CTP-543 Treatment - Mild Hepatic Impairment | Experimental | Not described Receives: Drug: CTP-543 |
| CTP-543 Treatment - Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose PK exposure: Maximum observed concentration (Cmax)
Maximum concentration, obtained directly from the observed concentration versus time data.
Measured: 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
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)
Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation)
Measured: 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
Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant
Measured: 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
Secondary outcomes (1)
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Measured: Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after the final administration of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jun 2022
- Primary completion15 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467722
- Sponsor's protocol ID
- CP543.1013
- Status last verified
- Nov 2022
- First submitted
- 30 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)
- ClinicalTrials.gov ID
- NCT05467722
- Acronym / sponsor ID
- CP543.1013
- Conditions
- Hepatic Impairment
- Keywords
- CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTP-543 Treatment - Mild Hepatic Impairment | Experimental | Drug: CTP-543 |
| CTP-543 Treatment - Moderate Hepatic Impairment | Experimental | Drug: CTP-543 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult males or females aged 18-75
- Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
- If 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
- Capable of giving informed consent and complying with study procedures
- For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening.
Key exclusion criteria (12 listed)
- History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Known history of any GI surgery or any condition possibly affecting drug absorption
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 470 msec for males or QTcF > 480 msec for females at Screening visit.
- Females who are nursing or pregnant prior to drug administration
- Positive for human immunodeficiency virus (HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTP-543Single 12 mg oral dose administered on Day 1 | Drug | CTP-543 Treatment - Mild Hepatic Impairment, CTP-543 Treatment - Moderate Hepatic Impairment |
Primary outcome
Single dose PK exposure: Maximum observed concentration (Cmax)
Time frame: 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
Maximum concentration, obtained directly from the observed concentration versus time data.
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)
Time frame: 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
Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation)
Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: 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
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant
1 secondary outcome
Assessment of Safety and Tolerability following administration of CTP-543
Time frame: Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after the final administration of study drug)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTP-543 in people with Hepatic Impairment, run by Concert Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single dose PK exposure: Maximum observed concentration (Cmax) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.