Healthy Volunteer
Conditions
Keywords
Healthy Volunteer
Brief summary
This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.
Interventions
DRUGTavapadon
Oral: Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | 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 |
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | Up to approximately 22 days | (Cmax) of Tavapadon |
| Time to Cmax (Tmax) of Tavapadon | Up to approximately 22 days | Tmax of Tavapadon |
| Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon | Up to approximately 22 days | Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon |
| Terminal Phase Elimination Half-life (t1/2) of Tavapadon | Up to approximately 22 days | Terminal Phase Elimination Half-life (t1/2) of Tavapadon |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon | Up to approximately 22 days | Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon | Up to approximately 22 days | Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon |
| Trough Concentration (Ctrough) of Tavapadon | Up to approximately 22 days | Trough Concentration (Ctrough) of Tavapadon |
Countries
United States
Outcome results
None listed