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Clinical trial

Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers

ID
Name
M24-231
Description
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.
Trial arms
Trial start
2023-10-05
Estimated PCD
2023-12-10
Trial end
2023-12-10
Status
Not yet recruiting
Phase
Early phase I
Treatment
ABBV-903
Tablet; oral
Arms:
Part 1, Sequence A, Part 1, Sequence B, Part 1, Sequence C, Part 2, Sequence A, Part 2, Sequence B
Size
30
Primary endpoint
Maximum Observed Plasma Concentration (Cmax) of ABBV-903
From 0 - 96 hours
Time to Cmax (Tmax) of ABBV-903
From 0 - 96 hours
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
From 0 - 96 hours
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
From 0 - 96 hours
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
From 0 - 96 hours
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
From 0 - 96 hours
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
From 0 - 96 hours
Number of Participants with Adverse Events
Up to 42 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-10-11

1 organization

1 product

1 indication

Organization
AbbVie
Product
ABBV-903
Indication
Healthy Control Participants