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

NCT ID: NCT03145948

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2017-08-16

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.

Conditions

Psoriasis

Keywords

Tolerability; Psoriasis; Pharmacokinetics; Safety; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A

Participants, who are healthy volunteers, receiving ABBV-553 dose A or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Arm B

Participants, who are healthy volunteers, receiving ABBV-553 dose B or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Arm C

Participants, who are healthy volunteers, receiving ABBV-553 dose C or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Arm D

Participants, who are healthy volunteers, receiving ABBV-553 dose D or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Arm E

Participants with psoriasis receiving ABBV-553 dose B or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Arm F

Participants with psoriasis receiving ABBV-553 dose C or placebo

Group Type: EXPERIMENTAL

ABBV-553

Intervention Type: DRUG

It is administered orally.

Placebo

Intervention Type: DRUG

It is administered orally.

Interventions

ABBV-553

It is administered orally.

Intervention Type: DRUG

Placebo

It is administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Countries

United States

Other Identifiers

M16-058

Identifier Type: -

Identifier Source: org_study_id