Assessing how well different oral forms of tavapadon are absorbed in healthy adults
A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets
This study is testing how well two different forms of the medication tavapadon are absorbed in healthy adults to find out which one works better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT06895356 on ClinicalTrials.gov |
What this trial studies
This study evaluates the relative bioavailability of two oral formulations of tavapadon in healthy adult participants. It aims to determine how effectively the body absorbs the medication from each formulation. Participants will undergo medical assessments to ensure they meet health criteria, and their responses to the drug will be monitored throughout the study. The findings could provide insights into the optimal formulation for future use.
Who should consider this trial
Good fit: Ideal candidates are healthy adult females with a specific BMI range and non-childbearing potential.
Not a fit: Patients with a history of epilepsy or significant cardiac or respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved formulations of tavapadon that enhance its effectiveness for patients.
How similar studies have performed: While this study focuses on a specific formulation assessment, similar studies assessing drug bioavailability have shown success in optimizing medication delivery.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 275870 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.