A Study to Assess the Relative Bioavailability of Oral ABBV-932 in Healthy Adult Participants
Assessment of the Relative Bioavailability of ABBV-932 Formulations in Healthy Adult Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: ABBVIE CALL CENTER
- Phone Number: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Study Locations
-
-
Illinois
-
Grayslake, Illinois, United States, 60030
- Acpru /Id# 266649
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ABBV-932: Arm A
Participants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm B
Participants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm C
Participants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm D
Participants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm E
Participants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm F
Participants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm G
Participants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal.
|
Oral Capsule
Oral tablet
|
|
Experimental: ABBV-932: Arm H
Participants will receive a single dose of ABBV-932 Arm H on day 1 under fasting conditions.
|
Oral Capsule
Oral tablet
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of ABBV-932
Time Frame: Up to approximately 6 days
|
Cmax of ABBV-932
|
Up to approximately 6 days
|
|
Time to Cmax (Tmax) of ABBV-932
Time Frame: Up to approximately 6 days
|
Tmax of ABBV-932
|
Up to approximately 6 days
|
|
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
|
Up to approximately 6 days
|
|
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
|
Up to approximately 6 days
|
|
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
|
Up to approximately 6 days
|
|
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
|
Up to approximately 6 days
|
|
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.
|
Up to approximately 180 days
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- M24-889
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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