This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis under non-fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
12
Anaheim Clinical Trials LLC /ID# 164101
Anaheim, California, United States
Providence Clinical Research /ID# 163867
Toluca, California, United States
Progressive Medical Research /ID# 163868
Port Orange, Florida, United States
Abbvie Clinical Pharmacology Research Unit /ID# 163866
Grayslake, Illinois, United States
Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553
Maximum observed plasma concentration (Cmax) of ABBV-553
Time frame: Day 1
Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553
Maximum observed plasma concentration (Cmax) of ABBV-553
Time frame: Day 1
Substudy 1: Time to Cmax (peak time, Tmax)
Time to Cmax (peak time, Tmax)
Time frame: Day 1
Substudy 2: Time to Cmax (peak time, Tmax)
Time to Cmax (peak time, Tmax)
Time frame: Day 1
Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Time frame: Day 1
Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Time frame: Day 1
Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough)
Observed plasma concentration at the end of the dosing interval (Ctrough)
Time frame: Day 7 and Day 14
Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough)
Observed plasma concentration at the end of the dosing interval (Ctrough)
Time frame: Day 28
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Substudy 1: Apparent clearance (CL/F)
Apparent clearance (CL/F)
Time frame: Day 14
Substudy 2: Apparent clearance (CL/F)
Apparent clearance (CL/F)
Time frame: Day 28
Substudy 1: Volume of distribution (Vβ/F)
Volume of distribution (Vβ/F)
Time frame: Day 14
Substudy 2: Volume of distribution (Vβ/F)
Volume of distribution (Vβ/F)
Time frame: Day 28
Substudy 1: Fraction excreted unchanged in urine (fe)
Fraction excreted unchanged in urine (fe)
Time frame: Day 14
Substudy 1: Apparent renal clearance (CLR)
Apparent renal clearance (CLR)
Time frame: Day 14
Substudy 2: Psoriasis Area and Severity Index (PASI)
Percent improvement in PASI from Baseline
Time frame: Day 28
Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores
Psoriasis subjects participating in Substudy 2 will complete the questionnaire at the designated clinic.
Time frame: Day 28