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

Description

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

Conditions

Healthy Volunteer

Study Overview

Study Details

Study overview

This study will assess the relative bioavailability of two different Oral formulations of 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

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

Condition
Healthy Volunteer
Intervention / Treatment

-

Contacts and Locations

Grayslake

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2025-06