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

NCT06895356 | Completed Phase 1

• 1 other identifier: M25-974
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

Tavapadon: Part 1-Sequence 1

EXPERIMENTAL

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

Drug: Tavapadon

Tavapadon: Part 1-Sequence 2

EXPERIMENTAL

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

Drug: Tavapadon

Tavapadon: Part 2-Sequence 1

EXPERIMENTAL

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

Tavapadon: Part 2-Sequence 2

EXPERIMENTAL

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

Interventions

Tavapadon DRUG

Oral: Tablet

Tavapadon: Part 1-Sequence 1; Tavapadon: Part 1-Sequence 2; Tavapadon: Part 2-Sequence 1; Tavapadon: Part 2-Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 275870

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: March 26, 2025
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)