Assessment of the Relative Bioavailability of ABBV-932 Formulations in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax) of ABBV-932
Study Overview
Brief Summary
This study will assess the relative bioavailability and effect of food on pharmacokinetics of ABBV-932 oral administration in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 and upon initial confinement. 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
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 any clinically significant sensitivity or allergy to any medication or food.
Arms & Interventions
ABBV-932: Arm E
Participants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm G
Participants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm B
Participants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm D
Participants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm C
Participants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm H
Participants will receive a single dose of ABBV-932 Arm H on day 1 under fasting conditions.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm A
Participants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions.
Intervention: ABBV-932 (Drug)
ABBV-932: Arm F
Participants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions.
Intervention: ABBV-932 (Drug)
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax) of ABBV-932
Time Frame: Up to approximately 6 days
Cmax of ABBV-932
Time to Cmax (Tmax) of ABBV-932
Time Frame: Up to approximately 6 days
Tmax of ABBV-932
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
Time Frame: Up to approximately 6 days
Terminal phase elimination rate constant (beta) of ABBV-932
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Time Frame: Up to approximately 6 days
Terminal phase elimination half-life of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Time Frame: Up to approximately 6 days
AUCt of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Time Frame: Up to approximately 6 days
AUCinf of ABBV-932
Number of Participants Experiencing Adverse Events
Time Frame: Up to approximately 180 days
An 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 Outcomes
No secondary outcomes reported