Status:
COMPLETED
A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06895356
Start Date
March 26 2025
End Date
June 16 2025
Last Update
June 26 2025
Active Locations (1)
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1
Acpru /Id# 275870
Grayslake, Illinois, United States, 60030