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

A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Tavapadon

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 275870

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tavapadon: Part 1-Sequence 1; Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2	Drug: Tavapadon; Oral: Tablet
Experimental: 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	Drug: Tavapadon; Oral: Tablet
Experimental: 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	Drug: Tavapadon; Oral: Tablet
Experimental: 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	Drug: Tavapadon; Oral: Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment	Up to approximately 53 days
Maximum Observed Plasma Concentration (Cmax) of Tavapadon	(Cmax) of Tavapadon	Up to approximately 22 days
Time to Cmax (Tmax) of Tavapadon	Tmax of Tavapadon	Up to approximately 22 days
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon	Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon	Up to approximately 22 days
Terminal Phase Elimination Half-life (t1/2) of Tavapadon	Terminal Phase Elimination Half-life (t1/2) of Tavapadon	Up to approximately 22 days
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon	Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon	Up to approximately 22 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon	Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon	Up to approximately 22 days
Trough Concentration (Ctrough) of Tavapadon	Trough Concentration (Ctrough) of Tavapadon	Up to approximately 22 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Other Study ID Numbers: M25-974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No