Healthy Volunteers
Conditions
Keywords
ABBV-903, Healthy Volunteers
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.
Interventions
DRUGABBV-903
Tablet; oral
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903 | From 0 - 96 hours | AUCinf 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. |
Countries
United States
Outcome results
None listed