Hepatic ImpairmentPhase 1NCT05404529
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
A Phase 1 study testing Tavapadon in people with Hepatic Impairment, run by Cerevel Therapeutics, LLC at 3 sites in United States.
Trial 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. 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?
- Tavapadon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2022to 24 Jan 2023
- 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
- 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)].
- Must meet the criteria for Class A or B of the modified Child-Pugh classification.
- Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
- 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).
Who cannot join
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.
- 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).
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
- Acute hepatitis.
- Grade ≥2 hepatic encephalopathy.
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- Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
- Primary biliary cholangitis or primary sclerosing cholangitis.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Miami, Florida
Miami, Florida, 33014
Orlando, Florida
Orlando, Florida, 32809
San Antonio, Texas
San Antonio, Texas, 78215
About this study
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
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.
- Conditions
- Hepatic Impairment
- Being tested
- Tavapadon
- Keywords
- Healthy Volunteer, Mild Hepatic Impairment, Moderate Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TavapadonDrug
Also called CVL-751
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tavapadon |
| 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. Receives: Drug: Tavapadon |
| 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. Receives: Drug: Tavapadon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Measured: 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
Measured: 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
Measured: pre-dose and at multiple timepoints post-dose up to Day 7
Secondary outcomes (6)
Number of Participants with Adverse Events (AEs) and AEs by Severity
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Measured: Day 1 up to Follow-up (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start29 Apr 2022
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404529
- Sponsor's protocol ID
- CVL-751-1003
- Status last verified
- May 2023
- First submitted
- 30 May 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05404529
- Acronym / sponsor ID
- CVL-751-1003
- Conditions
- Hepatic Impairment
- Keywords
- Healthy Volunteer, Mild Hepatic Impairment, Moderate Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 3 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Function | Experimental | Drug: TavapadonParticipants 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 | Drug: TavapadonParticipants 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 | Drug: TavapadonParticipants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)].
- Must meet the criteria for Class A or B of the modified Child-Pugh classification.
- Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
- 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 (9 listed)
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine or booster within 7 days of planned dosing.
- 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).
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
- Acute hepatitis.
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 |
|---|---|---|
| TavapadonAlso: CVL-751Oral tablets | Drug | Mild Hepatic Function, Moderate Hepatic Function, Normal Hepatic Function |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time frame: 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
Time frame: 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
Time frame: pre-dose and at multiple timepoints post-dose up to Day 7
6 secondary outcomes
Number of Participants with Adverse Events (AEs) and AEs by Severity
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Day 1 up to Follow-up (Day 15)
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 30 May 2023.
- Individual participant dataSharing planned: No
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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.
3 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 Tavapadon in people with Hepatic Impairment, run by Cerevel Therapeutics, LLC at 3 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 4 inclusion and 9 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Maximum Observed Plasma Concentration (Cmax) of Tavapadon (time frame: pre-dose and at multiple timepoints post-dose up to Day 7). 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 30 May 2023.