A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers
- Registration Number
- NCT06078202
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1, Sequence B ABBV-903 Participants will receive 1 dose of ABBV-903. Part 1, Sequence C ABBV-903 Participants will receive 1 dose of ABBV-903. Part 1, Sequence A ABBV-903 Participants will receive 1 dose of ABBV-903. Part 2, Sequence A ABBV-903 Participants will receive 1 dose of ABBV-903. Part 2, Sequence B ABBV-903 Participants will receive 1 dose of ABBV-903.
- Primary Outcome Measures
Name Time Method AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903 From 0 - 96 hours AUCinf of ABBV-903 will be assessed.
Maximum Observed Plasma Concentration (Cmax) of ABBV-903 From 0 - 96 hours Cmax of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903 From 0 - 96 hours Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903 From 0 - 96 hours BETA of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903 From 0 - 96 hours Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903 From 0 - 96 hours AUC0-24 of ABBV-903 will be assessed.
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903 From 0 - 96 hours AUCt of ABBV-903 will be assessed.
Number of Participants with Adverse Events Up to 42 days An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 259438
🇺🇸Grayslake, Illinois, United States