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The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Function | Experimental | Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1. |
|
| Mild Hepatic Function | Experimental | Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1. |
|
| Normal Hepatic Function | Experimental | Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon | pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon | pre-dose and at multiple timepoints post-dose up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and AEs by Severity | Day 1 up to Follow-up (Day 15) | |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values | Day 1 up to Follow-up (Day 15) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami, Florida | Miami | Florida | 33014 | United States | ||
| Orlando, Florida |
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| Number of Participants with Clinically Significant Abnormalities in Vital Sign Values | Day 1 up to Follow-up (Day 15) |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Values | Day 1 up to Follow-up (Day 15) |
| Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results | Day 1 up to Follow-up (Day 15) |
| Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score | Day 1 up to Follow-up (Day 15) |
| Orlando |
| Florida |
| 32809 |
| United States |
| San Antonio, Texas | San Antonio | Texas | 78215 | United States |