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

November 2, 2017 updated by: AbbVie

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research /ID# 163868
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Abbvie Clinical Pharmacology Research Unit /ID# 163866

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / 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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 9, 2017

Primary Completion (ACTUAL)

August 16, 2017

Study Completion (ACTUAL)

August 16, 2017

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (ACTUAL)

May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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