To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

• Sponsor: Cerevel Therapeutics, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05404529
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: Tavapadon	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following Single Dose of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
• Actual Study Start Date: Apr 29, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Hepatic Function Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.	Drug: Tavapadon; Oral tablets; Other Names: CVL-751
Experimental: Mild Hepatic Function Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.	Drug: Tavapadon; Oral tablets; Other Names: CVL-751
Experimental: Normal Hepatic Function Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.	Drug: Tavapadon; Oral tablets; Other Names: CVL-751

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of Tavapadon [pre-dose and at multiple timepoints post-dose up to Day 7]

2. 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]

3. 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]

Secondary Outcome Measures

1. Number of Participants with Adverse Events (AEs) and AEs by Severity [Day 1 up to Follow-up (Day 15)]

2. Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values [Day 1 up to Follow-up (Day 15)]

3. Number of Participants with Clinically Significant Abnormalities in Vital Sign Values [Day 1 up to Follow-up (Day 15)]

4. Number of Participants with Clinically Significant Abnormalities in Laboratory Values [Day 1 up to Follow-up (Day 15)]

5. Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results [Day 1 up to Follow-up (Day 15)]

6. Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score [Day 1 up to Follow-up (Day 15)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

1. Body mass index of ≥17.5 to 42.0 0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [110 pounds (lbs)].

2. Must meet the criteria for Class A or B of the modified Child-Pugh classification.

3. Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.

4. Previous alcohol abuse is permitted provided that the participant is willing and able to follow lifestyle guidelines and has a negative breath alcohol test at Screening and Check-in (Day -1).

Key Exclusion Criteria:

1. Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.

2. Have recently been diagnosed with symptomatic Coronavirus Disease 2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the informed consent form (ICF).

3. Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.

4. Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.

5. Acute hepatitis.

6. Grade ≥2 hepatic encephalopathy.

7. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.

8. Primary biliary cholangitis or primary sclerosing cholangitis.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Liver Institute American Research Corporation	San Antonio	Texas	United States	89326

Sponsors and Collaborators

• Cerevel Therapeutics, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerevel Therapeutics, LLC
• ClinicalTrials.gov Identifier: NCT05404529
• Other Study ID Numbers: CVL-751-1003
• First Posted: Jun 3, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cerevel Therapeutics, LLC: Healthy Volunteer; Mild Hepatic Impairment; Moderate Hepatic Impairment
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Jul 11, 2022