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

NCT03145948 | Terminated Phase 1 FDA Drug

• 1 other identifier: M16-058
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (14)

• Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553

  Maximum observed plasma concentration (Cmax) of ABBV-553

  Day 1

• Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553

  Maximum observed plasma concentration (Cmax) of ABBV-553

  Day 1

• Substudy 1: Time to Cmax (peak time, Tmax)

  Time to Cmax (peak time, Tmax)

  Day 1

• Substudy 2: Time to Cmax (peak time, Tmax)

  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

  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

  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)

  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)

  Observed plasma concentration at the end of the dosing interval (Ctrough)

  Day 28

• Substudy 1: Apparent clearance (CL/F)

  Apparent clearance (CL/F)

  Day 14

• Substudy 2: Apparent clearance (CL/F)

  Apparent clearance (CL/F)

  Day 28

• Substudy 1: Volume of distribution (Vβ/F)

  Volume of distribution (Vβ/F)

  Day 14

• Substudy 2: Volume of distribution (Vβ/F)

  Volume of distribution (Vβ/F)

  Day 28

• Substudy 1: Fraction excreted unchanged in urine (fe)

  Fraction excreted unchanged in urine (fe)

  Day 14

• Substudy 1: Apparent renal clearance (CLR)

  Apparent renal clearance (CLR)

  Day 14

Secondary Outcomes (2)

• Substudy 2: Psoriasis Area and Severity Index (PASI)

  Day 28

• Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores

  Day 28

Study Arms (6)

Arm A

EXPERIMENTAL

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

Drug: ABBV-553; Drug: Placebo

Arm B

EXPERIMENTAL

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

Drug: ABBV-553; Drug: Placebo

Arm C

EXPERIMENTAL

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

Drug: ABBV-553; Drug: Placebo

Arm D

EXPERIMENTAL

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

Drug: ABBV-553; Drug: Placebo

Arm E

EXPERIMENTAL

Participants with psoriasis receiving ABBV-553 dose B or placebo

Drug: ABBV-553; Drug: Placebo

Arm F

EXPERIMENTAL

Participants with psoriasis receiving ABBV-553 dose C or placebo

Drug: ABBV-553; Drug: Placebo

Interventions

ABBV-553 DRUG

It is administered orally.

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Placebo DRUG

It is administered orally.

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Anaheim Clinical Trials LLC /ID# 164101

Anaheim, California, 92801, United States

Location

Providence Clinical Research /ID# 163867

Toluca, California, 91606, United States

Location

Progressive Medical Research /ID# 163868

Port Orange, Florida, 32127, United States

Location

Abbvie Clinical Pharmacology Research Unit /ID# 163866

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 9, 2017
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (4)