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Completed

NCT Number: NCT06895356

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 275870

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tavapadon

Drug

Oral: Tablet

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: 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

  2. Maximum Observed Plasma Concentration (Cmax) of Tavapadon

    Time frame: Up to approximately 22 days

    (Cmax) of Tavapadon

  3. Time to Cmax (Tmax) of Tavapadon

    Time frame: Up to approximately 22 days

    Tmax of Tavapadon

  4. Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon

    Time frame: Up to approximately 22 days

    Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon

  5. Terminal Phase Elimination Half-life (t1/2) of Tavapadon

    Time frame: Up to approximately 22 days

    Terminal Phase Elimination Half-life (t1/2) of Tavapadon

  6. Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon

    Time frame: Up to approximately 22 days

    Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon

  7. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon

    Time frame: Up to approximately 22 days

    Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon

  8. Trough Concentration (Ctrough) of Tavapadon

    Time frame: Up to approximately 22 days

    Trough Concentration (Ctrough) of Tavapadon

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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