Healthy SubjectsPhase 1NCT04241393

An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects

A Phase 1 study testing Tavapadon tablet and Tavapadon [14C] suspension in people with Healthy Subjects, run by Cerevel Therapeutics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Tavapadon tablet and Tavapadon [14C] suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2020to 8 Nov 2020
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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male subjects, ages 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
Body mass index (BMI) of 18.0 to 32.0 kg/m2 and a total body weight > 50 kg (110 lbs).
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the investigator (or designee).
Male subjects with a pregnant or a nonpregnant partner of childbearing potential must agree to use an acceptable or a highly effective method of contraception from signing of informed consent during the trial, and for 7 days following the last dose of study drug.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
Capable of consuming the standard diet.
History of a minimum of 1 bowel movement per day.

Who cannot join

Medical History and Concurrent Diseases
Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the 12 months prior to signing ICF.
Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity. Subjects with a history of febrile seizures and/or history of head trauma with loss of consciousness requiring hospitalization overnight will be excluded as well.
Subjects with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
Medical conditions that are minor or well controlled may be considered acceptable if the condition does not expose the subject to an undue risk of a significant AE or interfere with the assessments of safety during the course of the trial. The medical monitor should be contacted in any instance where the investigator is uncertain regarding the stability of a subject's medical conditions(s) and the potential impact of the condition(s) on trial participation.
Any condition possibly affecting drug absorption including history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy and bariatric weight loss surgeries will not be allowed).

Show all 38Show fewer

History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the ICF.
History of regular alcohol consumption exceeding 14 drinks/week [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months prior to signing ICF.
Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
Subjects who answer "yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR
Subjects who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR
Subjects who, in the opinion of the investigator, present a serious risk of suicide.
Subjects who have attempted suicide in the past.
Physical Examination and Clinical Laboratory Results
Positive hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and/or positive human immunodeficiency virus test (HIV-1 and HIV-2 antibody) at Screening.
Positive urine drug screen (with cotinine) or positive alcohol breathalyzer at Screening and Check-in. Subjects with a positive drug screen for illicit drugs or cotinine are excluded and may not be retested or rescreened. Subjects with a positive urine drug screen resulting from use of marijuana (any cannabinoids), prescription medications, over-the-counter medications, or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the subject or interpretation of the trial results may continue evaluation for the trial following consultation and explicit approval by the medical monitor.
Subjects with a 12-lead ECG demonstrating the following:
QT interval corrected for heart rate using Fridericia's formula >450 msec (average of 3 ECGs obtained at the Screening Visit).
Subjects with any of the following abnormalities in clinical laboratory tests at the Screening Visit, confirmed by a single repeat measurement, if deemed necessary, and at the discretion of the investigator:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 × upper limit of normal (ULN)
Total bilirubin ≥1.5 × ULN.
Subjects with other abnormal laboratory test results, vital sign results, or ECG findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the subjects or the interpretation of the trial results. The medical monitor should be contacted to discuss individual cases, as needed.
Tests with exclusionary results should be repeated to ensure reproducibility of the abnormality before excluding a subject based on criteria provided in the protocol. For ECGs, 3 consecutive recordings are required and if 2 of the 3 remain exclusionary, then the subject is not eligible for the trial.
Disallowed Prior and Concomitant Medications
Subjects taking other prohibited medication or who would be likely to require prohibited concomitant therapy during the trial.
Other
Subjects with difficulty swallowing.
Subjects who are known to be allergic or hypersensitive to the IMP or any of its components.
Subjects who are known to be allergic or hypersensitive to contents of the standard diet.
Subjects who have participated in any clinical trial involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
Receipt of blood products within 2 months prior to Check-in.
Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Poor peripheral venous access.
Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
Subjects who have participated in a radiolabeled drug trial where exposures are known to the investigator within the previous 4 months prior to admission to the clinic for this trial or participated in a radiolabeled drug trial where exposures are not known to the investigator within the previous 6 months prior to admission to the clinic for this trial. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled trials within 4 to 12 months prior to this trial will be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure with consideration given to the half-lives of the previous radiolabeled trial drugs received.
Any subject who, in the opinion of the sponsor, investigator, or medical monitor, should not participate in the trial.
Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator.
Unwilling or unable to comply with the lifestyle modifications described in this protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: An Open-label Trial to Evaluate the Absorption, Metabolism, and Excretion of a Single Dose of [14C]-Tavapadon in Healthy Adult Male Subjects at Steady State

The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.

Conditions: Healthy Subjects
Being tested: Tavapadon tablet, Tavapadon [14C] suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tavapadon tabletDrug
Participants will receive multiple dose titration of Tavapadon (0.25 mg once daily [QD] on Days 1 to 3, 0.5 mg QD on Days 4 to 6, 1.0 mg QD on Days 7 to 9, 1.5 mg QD on Days 10 to 12, and 2.5 mg QD on Days 13 to 15)
Tavapadon [14C] suspensionDrug
Following 15-Day multiple dose titration of Tavapadon, participants will receive a single oral dose of Tavapadon 2.5 mg containing approximately 100 μCi of [14C] Tavapadon on Day 16

Study groups in NCT04241393
Study group	Role	What they receive
Tavapadon	Experimental	Not described Receives: Drug: Tavapadon tablet; Drug: Tavapadon [14C] suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics of [14C]-Tavapadon and Metabolites: Area under the radioactivity time curve from zero to infinity (AUCinf) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Area under the radioactivity time curve from time 0 to last quantifiable concentration (AUClast) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Peak radioactivity Cmax) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Time to last measurable radioactivity (Tlast) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Time to maximum radioactivity (Tmax) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: elimination half-life (t½) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Measured: Day 16 up to Day 28
Pharmacokinetics of Tavapadon: Apparent total body clearance (CL/F) for Tavapadon
Measured: Day 16 up to Day 28
Pharmacokinetics of Tavapadon: Apparent volume of distribution (Vz/F) for Tavapadon
Measured: Day 16 up to Day 28
Ratio of Plasma AUCinf for Tavapadon to whole blood total Radioactivity AUCinf
Measured: Day 16 up to Day 28
Ratio of Plasma AUCinf for Metabolites (PF-06752844) to whole blood total Radioactivity AUCinf
Measured: Day 16 up to Day 28
Ratio of plasma AUCinf for Metabolites (PF-06752844) to plasma AUCinf for Tavapadon
Measured: Day 16 up to Day 28
Ratio of whole blood AUCinf for Tavapadon (and metabolites, measured as total radioactivity) to plasma AUCinf for Tavapadon (and metabolites, measured as total radioactivity)
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Total radioactivity in urine at different intervals
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative radioactivity excreted in urine (Cumulative Aeu)
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Fraction of the dose administered excreted in urine (Feu) for total radioactivity at different intervals
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative fraction of the dose administered excreted in urine (Cumulative Feu) for total radioactivity in urine
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Amount eliminated in feces (Aef) for total radioactivity in feces at different intervals
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative amount excreted in feces (Cumulative Aef) for total radioactivity in feces
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Fraction of the dose administered excreted in feces (Fef) for total radioactivity in feces at different intervals
Measured: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative Fraction of the dose administered excreted in feces (Cumulative Fef) for total radioactivity in feces
Measured: Day 16 up to Day 28

Secondary outcomes (5)

Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 28
Number of subjects with Clinically significant changes in Electrocardiogram measures (PR,RR,QT and QTcF)
Measured: Up to Day 28
Number of subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
Measured: Up to Day 28
Number of subjects with clinically significant changes in laboratory measures
Measured: Up to Day 28
Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Measured: At Baseline and up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20208 Nov 2020

First posted27 Jan 2020
Study start4 Feb 2020
Primary completion8 Nov 2020
Study completion8 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04241393
Sponsor's protocol ID: CVL-751-HV-001
Status last verified: Nov 2020
First submitted: 22 Jan 2020
Last updated: 17 Nov 2020
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Trial to Evaluate the Absorption, Metabolism, and Excretion of a Single Dose of [14C]-Tavapadon in Healthy Adult Male Subjects at Steady State
ClinicalTrials.gov ID: NCT04241393
Acronym / sponsor ID: CVL-751-HV-001
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
Study start: 4 Feb 2020 (actual)
Primary completion: 8 Nov 2020 (actual)
Study completion: 8 Nov 2020 (actual)
First posted: 27 Jan 2020 (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 purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tavapadon	Experimental	Drug: Tavapadon tablet, Drug: Tavapadon [14C] suspension

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male subjects, ages 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
Body mass index (BMI) of 18.0 to 32.0 kg/m2 and a total body weight > 50 kg (110 lbs).
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the investigator (or designee).
Male subjects with a pregnant or a nonpregnant partner of childbearing potential must agree to use an acceptable or a highly effective method of contraception from signing of informed consent during the trial, and for 7 days following the last dose of study drug.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Key exclusion criteria (38 listed)

Medical History and Concurrent Diseases
Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the 12 months prior to signing ICF.
Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity. Subjects with a history of febrile seizures and/or history of head trauma with loss of consciousness requiring hospitalization overnight will be excluded as well.
Subjects with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
Medical conditions that are minor or well controlled may be considered acceptable if the condition does not expose the subject to an undue risk of a significant AE or interfere with the assessments of safety during the course of the trial. The medical monitor should be contacted in any instance where the investigator is uncertain regarding the stability of a subject's medical conditions(s) and the potential impact of the condition(s) on trial participation.

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
Tavapadon tabletParticipants will receive multiple dose titration of Tavapadon (0.25 mg once daily [QD] on Days 1 to 3, 0.5 mg QD on Days 4 to 6, 1.0 mg QD on Days 7 to 9, 1.5 mg QD on Days 10 to 12, and 2.5 mg QD on Days 13 to 15)	Drug	Tavapadon
Tavapadon [14C] suspensionFollowing 15-Day multiple dose titration of Tavapadon, participants will receive a single oral dose of Tavapadon 2.5 mg containing approximately 100 μCi of [14C] Tavapadon on Day 16	Drug	Tavapadon

Primary outcome

Pharmacokinetics of [14C]-Tavapadon and Metabolites: Area under the radioactivity time curve from zero to infinity (AUCinf) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Area under the radioactivity time curve from time 0 to last quantifiable concentration (AUClast) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Peak radioactivity Cmax) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Time to last measurable radioactivity (Tlast) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: Time to maximum radioactivity (Tmax) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon and Metabolites: elimination half-life (t½) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood
Time frame: Day 16 up to Day 28
Pharmacokinetics of Tavapadon: Apparent total body clearance (CL/F) for Tavapadon
Time frame: Day 16 up to Day 28
Pharmacokinetics of Tavapadon: Apparent volume of distribution (Vz/F) for Tavapadon
Time frame: Day 16 up to Day 28
Ratio of Plasma AUCinf for Tavapadon to whole blood total Radioactivity AUCinf
Time frame: Day 16 up to Day 28
Ratio of Plasma AUCinf for Metabolites (PF-06752844) to whole blood total Radioactivity AUCinf
Time frame: Day 16 up to Day 28
Ratio of plasma AUCinf for Metabolites (PF-06752844) to plasma AUCinf for Tavapadon
Time frame: Day 16 up to Day 28
Ratio of whole blood AUCinf for Tavapadon (and metabolites, measured as total radioactivity) to plasma AUCinf for Tavapadon (and metabolites, measured as total radioactivity)
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Total radioactivity in urine at different intervals
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative radioactivity excreted in urine (Cumulative Aeu)
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Fraction of the dose administered excreted in urine (Feu) for total radioactivity at different intervals
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative fraction of the dose administered excreted in urine (Cumulative Feu) for total radioactivity in urine
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Amount eliminated in feces (Aef) for total radioactivity in feces at different intervals
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative amount excreted in feces (Cumulative Aef) for total radioactivity in feces
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Fraction of the dose administered excreted in feces (Fef) for total radioactivity in feces at different intervals
Time frame: Day 16 up to Day 28
Pharmacokinetics of [14C]-Tavapadon: Cumulative Fraction of the dose administered excreted in feces (Cumulative Fef) for total radioactivity in feces
Time frame: Day 16 up to Day 28

5 secondary outcomes

Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 28
Number of subjects with Clinically significant changes in Electrocardiogram measures (PR,RR,QT and QTcF)
Time frame: Up to Day 28
Number of subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
Time frame: Up to Day 28
Number of subjects with clinically significant changes in laboratory measures
Time frame: Up to Day 28
Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: At Baseline and up to Day 28

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 17 Nov 2020.

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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.

Matthew Leoni, MD study director

Cerevel Therapeutics, LLC

1 site 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 tablet and Tavapadon [14C] suspension in people with Healthy Subjects, run by Cerevel Therapeutics, LLC at 1 site 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 8 inclusion and 38 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Pharmacokinetics of [14C]-Tavapadon and Metabolites: Area under the radioactivity time curve from zero to infinity (AUCinf) for Tavapadon and Metabolites (PF-06752844), in plasma and whole blood (time frame: Day 16 up to Day 28). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04241393.

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 17 Nov 2020.