Clinical trial NCT03145948: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Tolerability
Psoriasis
Pharmacokinetics
Safety
Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria: - Male or female and between 18 and 55 years of age, inclusive, for Substudy 1, OR between 18 and 75 years of age, inclusive, for Substudy 2.

* If female, participant must be of non-child bearing potential defined as either:

  a. Postmenopausal: Age \> 55 years with no menses for 12 or more months without an alternative medical cause. Postmenopausal: Age \<= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level \>= 40 IU/L (OR) b. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
* Non-postmenopausal females must have a negative urine pregnancy test result at Screening, and a negative serum pregnancy test result on Day -2 or Day -1.
* Male participants who are sexually active with women of child bearing potential (WOCBP), even if the male participant has undergone a successful vasectomy, must agree to use condoms from Day 1 through at least 30 days after the last dose of study drug, and male participant agrees not to donate sperm at least 30 days after the last dose of study drug.
* Body Mass Index (BMI) \>= 18.0 to \<= 29.9 kg/m2 after rounding to the tenths decimal for Substudy 1 OR BMI \>= 18.0 to \<= 34.9 kg/m2 after rounding to the tenths decimal for Substudy 2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
* In the opinion of the Investigator, that the participant is in 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).
* Must voluntarily sign and date each informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures and be willing to comply with the requirements of this study protocol.

Additional criteria for Substudy 2:

* Has a clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months).
* Has a Psoriasis Area and Severity Index (PASI) score ≥ 12.
* Has a Static Physician's Global Assessment (sPGA) score ≥ 3.
* Has a Body Surface Area (BSA) affected by Ps ≥ 10%. Exclusion Criteria: - Male participant who is considering fathering a child or donating sperm during the study or through 30 days after the last dose of study drug.
* History of clinically significant sensitivity to any drug.
* History of epilepsy, any clinically significant cardiac (including any family history of long-QT syndrome or unexplained sudden death), respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
* Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the start of confinement (Day -2 or Day -1) or oral anti-infectives within 14 days prior to the start of confinement (Day -2 or Day -1)..
* Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.
* Use of any medications, vitamins and/or herbal supplements within the 2-week period prior to study drug administration. For Substudy 2, medications used to treat chronic, stable medical conditions are allowed during screening and participation in the study unless the medication is specifically prohibited.

Primary outcomes:
measure: Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553
timeFrame: Day 1
measure: Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553
timeFrame: Day 1
measure: Substudy 1: Time to Cmax (peak time, Tmax)
timeFrame: Day 1
measure: Substudy 2: Time to Cmax (peak time, Tmax)
timeFrame: Day 1
measure: Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
timeFrame: Day 1
measure: Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
timeFrame: Day 1
measure: Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough)
timeFrame: Day 7 and Day 14
measure: Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough)
timeFrame: Day 28
measure: Substudy 1: Apparent clearance (CL/F)
timeFrame: Day 14
measure: Substudy 2: Apparent clearance (CL/F)
timeFrame: Day 28
measure: Substudy 1: Volume of distribution (Vβ/F)
timeFrame: Day 14
measure: Substudy 2: Volume of distribution (Vβ/F)
timeFrame: Day 28
measure: Substudy 1: Fraction excreted unchanged in urine (fe)
timeFrame: Day 14
measure: Substudy 1: Apparent renal clearance (CLR)
timeFrame: Day 14
Secondary outcomes:
measure: Substudy 2: Psoriasis Area and Severity Index (PASI)
timeFrame: Day 28
measure: Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores
timeFrame: Day 28
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 164101
state: California
city: Toluca
country: United States
facility: Providence Clinical Research /ID# 163867
state: California
city: Port Orange
country: United States
facility: Progressive Medical Research /ID# 163868
state: Florida
city: Grayslake
country: United States
facility: Abbvie Clinical Pharmacology Research Unit /ID# 163866
state: Illinois
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: