Clinical trial NCT06895356: A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants
Official title: A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 53 days
measure: Maximum Observed Plasma Concentration (Cmax) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Time to Cmax (Tmax) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Terminal Phase Elimination Half-life (t1/2) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
timeFrame: Up to approximately 22 days
measure: Trough Concentration (Ctrough) of Tavapadon
timeFrame: Up to approximately 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 275870
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: