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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Healthy participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in control healthy participants matching the age, sex and weight with hepatic impaired participants |
|
| Group 2 Moderate Hepatic impaired participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in Moderate Hepatic impaired participants (Child-Pugh class B) |
|
| Group 3 Severe Hepatic impaired participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in Severe Hepatic impaired participants (Child-Pugh class C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palovarotene | Drug | A single dose of maximum 10 mg of palovarotene will be administered orally on Day 1 to healthy control participants with normal hepatic function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma drug concentration (Cmax) | Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 hours after dosing | Over 96 hours postdose |
| Unbound fraction of drug in plasma (fu) | Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 h after dosing | Over 96 hours postdose |
| Time to maximum observed plasma concentration (Tmax) | Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound) | Over 96 hours postdose |
| Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUC0-∞) | Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound) | Over 96 hours postdose |
| AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast) | Measure of AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast) (total and unbound) | Over 96 hours postdose |
| Apparent terminal elimination half life (T1/2) | Measure of apparent terminal elimination half-life over 96 hours post-dose | Over 96 hours postdose |
| Apparent terminal elimination rate constant (λz). | Measure of apparent terminal elimination rate constant (λz) over 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Adverse Events (AEs) | An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | From Baseline to Day 10 |
| Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ERG - Clinical Pharmacology of Miami | Miami | Florida | 33172 | United States | ||
| Orlando Clinical Research Center |
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| Palovarotene | Drug | A single 10 mg dose of palovarotene will be administered orally on Day 1 to Moderate hepatic impaired participants (Child-Pugh class B) |
|
| Palovarotene | Drug | A single 10 mg dose of either 5 mg or 10 mg of palovarotene will be administered orally on Day 1 to Severe hepatic impaired participants (Child-Pugh class C). |
|
| Over 96 hours postdose |
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator. |
| At Day 2, Day 5 and Day 10 |
| Percentage of participants with clinically significant change from baseline in physical examinations | Clinically significant changes in physical examinations will be reported. The clinical significance will be graded by the investigator. | At Day 1, 2 and 3, Day 5 and Day 10 |
| Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs | Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator. | At Day 1, 2 and 3, Day 5 and Day 10 |
| Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings | At Day 1, 2 and 3, Day 5 and Day 10 |
| Orlando |
| Florida |
| 32809 |
| United States |
| American Research Corporation/Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| C546535 | Palovarotene |
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