This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Altasciences Clinical Los Angeles /ID# 280183
Cypress, California, United States
Acpru /Id# 270279
Grayslake, Illinois, United States
Number of Participants with Adverse Events Reported During Safety Evaluations
Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.
Time frame: Up to Day 44
Maximum Plasma Concentration (Cmax) of ABBV-722
Cmax of ABBV-722.
Time frame: Up to Day 21
Time to Cmax (Tmax) of ABBV-722
Tmax of ABBV-722.
Time frame: Up to Day 21
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
AUCt of ABBV-722.
Time frame: Up to Day 8
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
AUCinf of ABBV-722
Time frame: Up to Day 8
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
Ctrough of ABBV-722.
Time frame: Up to Day 21
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
AUC from AUCtau following the first and last doses of ABBV-722.
Time frame: Up to Day 21
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
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Beta of ABBV-722.
Time frame: Up to Day 21
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
t1/2 of ABBV-722.
Time frame: Up to Day 21
Dose Normalized Cmax
Dose normalized Cmax.
Time frame: Up to Day 21
Dose Normalized AUCs
Dose normalized AUCs.
Time frame: Up to Day 21