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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Tavapadon

• Registration Number: NCT06895356
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study Start: 2025-03-26
• Study First Posted: 2025-03-26
• Status Verified: 2025-06
• Primary Completion: 2025-06-16
• Study Completion: 2025-06-16
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tavapadon: Part 1-Sequence 1	Tavapadon	Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2
Tavapadon: Part 1-Sequence 2	Tavapadon	Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2
Tavapadon: Part 2-Sequence 1	Tavapadon	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
Tavapadon: Part 2-Sequence 2	Tavapadon	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	Up to approximately 53 days	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
Maximum Observed Plasma Concentration (Cmax) of Tavapadon	Up to approximately 22 days	(Cmax) of Tavapadon
Time to Cmax (Tmax) of Tavapadon	Up to approximately 22 days	Tmax of Tavapadon
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon	Up to approximately 22 days	Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
Terminal Phase Elimination Half-life (t1/2) of Tavapadon	Up to approximately 22 days	Terminal Phase Elimination Half-life (t1/2) 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 Over the Dosing Interval (AUCτ) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon	Up to approximately 22 days	Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Trough Concentration (Ctrough) of Tavapadon	Up to approximately 22 days	Trough Concentration (Ctrough) of Tavapadon

Trial Locations

Locations (1)

Acpru /Id# 275870; 🇺🇸 Grayslake, Illinois, United States