A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2025-06-16

Brief Summary

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This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tavapadon: Part 1-Sequence 1

Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral: Tablet

Tavapadon: Part 1-Sequence 2

Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral: Tablet

Tavapadon: Part 2-Sequence 1

Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral: Tablet

Tavapadon: Part 2-Sequence 2

Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3

Group Type EXPERIMENTAL

Tavapadon

Intervention Type DRUG

Oral: Tablet

Interventions

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Tavapadon

Oral: Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
* Females, Non-Childbearing Potential due to meeting the following criteria:

* Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
* Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
* Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.

Exclusion Criteria

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity rating scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
* Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes