This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
72
CenExel ACT- Anaheim Clinical Trials /ID# 276423
Anaheim, California, United States
Acpru /Id# 270552
Grayslake, Illinois, United States
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
Cmax of ABBV-1088
Time frame: Up to approximately 24 days
Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088
Tmax of ABBV-1088
Time frame: Up to approximately 24 days
Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Terminal phase elimination rate constant (beta) of ABBV-1088
Time frame: Up to approximately 24 days
Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Terminal phase elimination half-life of ABBV-1088
Time frame: Up to approximately 24 days
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088
AUCt of ABBV-1088
Time frame: Up to approximately 24 days
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088
AUCinf of ABBV-1088
Time frame: Up to approximately 24 days
Number of Participants with Adverse Events (AEs)
An adverse event (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 An adverse event (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. The investigator assesses the relationship of each event to the use of study
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Time frame: Up to approximately 54 days
Part 1: Trough Concentration (Ctrough) of ABBV-1088
Ctrough of of ABBV-1088
Time frame: Up to approximately 24 days
Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Time frame: Up to approximately 24 days