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Clinical trial

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

ID
Name
M24-226
Description
The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.
Trial arms
Trial start
2023-04-18
Estimated PCD
2023-06-20
Trial end
2023-06-20
Status
Completed
Phase
Early phase I
Treatment
ABBV-903 Tablet Form 1
Oral Tablets
Arms:
Part 1: Sequence A, Part 1: Sequence B, Part 2: Sequence A, Part 2: Sequence B
ABBV-903 Tablet Form 2
Oral Tablets
Arms:
Part 1: Sequence A, Part 1: Sequence B, Part 2: Sequence A, Part 2: Sequence B
Size
24
Primary endpoint
Number of Participants with Adverse Events (AEs)
Up to Approximately 44 days
Maximum Plasma Concentration (Cmax) of ABBV-903
Up to approximately 14 days
Time to Cmax (Tmax) of ABBV-903
Up to approximately 14 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
Up to approximately 14 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
Up to approximately 14 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
Up to approximately 14 days
Eligibility criteria
Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth. * Negative test result for SARS-CoV-2 infection at screening visit 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 ECG. Exclusion Criteria: * 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. * History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2023-07-17

1 organization

1 product

1 indication

Organization
AbbVie
Product
ABBV-903
Indication
Healthy Volunteer