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
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Anaheim Clinical Trials LLC /ID# 164101
-
Toluca, California, United States, 91606
- Providence Clinical Research /ID# 163867
-
-
Florida
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Port Orange, Florida, United States, 32127
- Progressive Medical Research /ID# 163868
-
-
Illinois
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Grayslake, Illinois, United States, 60030
- Abbvie Clinical Pharmacology Research Unit /ID# 163866
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Arm A
Participants, who are healthy volunteers, receiving ABBV-553 dose A or placebo
|
It is administered orally.
It is administered orally.
|
|
EXPERIMENTAL: Arm B
Participants, who are healthy volunteers, receiving ABBV-553 dose B or placebo
|
It is administered orally.
It is administered orally.
|
|
EXPERIMENTAL: Arm C
Participants, who are healthy volunteers, receiving ABBV-553 dose C or placebo
|
It is administered orally.
It is administered orally.
|
|
EXPERIMENTAL: Arm D
Participants, who are healthy volunteers, receiving ABBV-553 dose D or placebo
|
It is administered orally.
It is administered orally.
|
|
EXPERIMENTAL: Arm E
Participants with psoriasis receiving ABBV-553 dose B or placebo
|
It is administered orally.
It is administered orally.
|
|
EXPERIMENTAL: Arm F
Participants with psoriasis receiving ABBV-553 dose C or placebo
|
It is administered orally.
It is administered orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553
Time Frame: Day 1
|
Maximum observed plasma concentration (Cmax) of ABBV-553
|
Day 1
|
|
Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553
Time Frame: Day 1
|
Maximum observed plasma concentration (Cmax) of ABBV-553
|
Day 1
|
|
Substudy 1: Time to Cmax (peak time, Tmax)
Time Frame: Day 1
|
Time to Cmax (peak time, Tmax)
|
Day 1
|
|
Substudy 2: Time to Cmax (peak time, Tmax)
Time Frame: Day 1
|
Time to Cmax (peak time, Tmax)
|
Day 1
|
|
Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Time Frame: Day 1
|
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
|
Day 1
|
|
Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Time Frame: Day 1
|
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
|
Day 1
|
|
Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough)
Time Frame: Day 7 and Day 14
|
Observed plasma concentration at the end of the dosing interval (Ctrough)
|
Day 7 and Day 14
|
|
Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough)
Time Frame: Day 28
|
Observed plasma concentration at the end of the dosing interval (Ctrough)
|
Day 28
|
|
Substudy 1: Apparent clearance (CL/F)
Time Frame: Day 14
|
Apparent clearance (CL/F)
|
Day 14
|
|
Substudy 2: Apparent clearance (CL/F)
Time Frame: Day 28
|
Apparent clearance (CL/F)
|
Day 28
|
|
Substudy 1: Volume of distribution (Vβ/F)
Time Frame: Day 14
|
Volume of distribution (Vβ/F)
|
Day 14
|
|
Substudy 2: Volume of distribution (Vβ/F)
Time Frame: Day 28
|
Volume of distribution (Vβ/F)
|
Day 28
|
|
Substudy 1: Fraction excreted unchanged in urine (fe)
Time Frame: Day 14
|
Fraction excreted unchanged in urine (fe)
|
Day 14
|
|
Substudy 1: Apparent renal clearance (CLR)
Time Frame: Day 14
|
Apparent renal clearance (CLR)
|
Day 14
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substudy 2: Psoriasis Area and Severity Index (PASI)
Time Frame: Day 28
|
Percent improvement in PASI from Baseline
|
Day 28
|
|
Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores
Time Frame: Day 28
|
Psoriasis subjects participating in Substudy 2 will complete the questionnaire at the designated clinic.
|
Day 28
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- M16-058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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