Palovarotene for Liver Disease

Recruiting at 73 trial locations

Overseen By Ipsen Clinical Study Enquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ipsen

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Cardiovascular, Respiratory, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 5 days

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function. The study will also assess the safety and tolerability of the single dose of palovarotene. Participants will be enrolled in stages and divided into three groups based on their liver function: * Group 1: Healthy participants with normal liver function * Group 2: Participants with moderate liver impairment * Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable) Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants with liver impairment may take other medications if approved by the investigator. It's best to discuss your specific medications with the trial team.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

This trial is for adults with moderate or severe liver impairment, and healthy adults with normal liver function. Participants must be able to stay in the clinical unit until Day 5 and return on Day 10. Specific details about who can join are not provided here.

Inclusion Criteria

Contraceptive use by men or women should be consistent with local regulations regarding methods of contraception for those participating in clinical trials

A stable medication regimen, defined as not starting new therapy(ies) or significantly changing dosage(s) within 30 days prior to dosing

I am between 18 and 70 years old.

Exclusion Criteria

I don't have conditions that affect how drugs work in my body.

I have had hepatitis B or C for less than 6 months, or I have stable chronic HCV.

I have been diagnosed with a liver or bile duct condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of palovarotene and are monitored for pharmacokinetics and safety

5 days

In-patient stay until Day 5

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 days

Final visit on Day 10

Treatment Details

Interventions

• Palovarotene

Trial Overview The study tests how a single dose of palovarotene (up to 10 mg) is processed by people with different levels of liver health. It's divided into three groups: one for those with normal liver function, another for moderate impairment, and a third for severe impairment if it's safe.

Participant Groups

Group I: Group 3 Severe Hepatic impaired participants Experimental Treatment 1 Intervention

Evaluation of the pharmacokinetics of IPN60120 in Severe Hepatic impaired participants (Child-Pugh class C)

Group II: Group 2 Moderate Hepatic impaired participants Experimental Treatment 1 Intervention

Evaluation of the pharmacokinetics of IPN60120 in Moderate Hepatic impaired participants (Child-Pugh class B)

Group III: Group 1 Healthy participants Experimental Treatment 1 Intervention

Evaluation of the pharmacokinetics of IPN60120 in control healthy participants matching the age, sex and weight with hepatic impaired participants

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD