A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Subjects With Chronic Plaque Psoriasis
Overview
- Phase
- Phase 1
- Intervention
- ABBV-157
- Conditions
- Psoriasis
- Sponsor
- AbbVie
- Enrollment
- 65
- Locations
- 10
- Primary Endpoint
- Substudy 2: Trough Concentration (Ctrough) of ABBV-157
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of ABBV-157 in the participants with psoriasis. This study consists of two substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Volunteer should be between 18 and 55 years of age and in general good health for Substudy 1 and participant with moderate to severe chronic plaque psoriasis between 18 and 75 years of age for Substudy 2 at the time of enrollment.
- •Participant should meet the laboratory assessments as mentioned in the protocol.
Exclusion Criteria
- •Participant has a history of epilepsy, any significant cardiac, respiratory, renal, hepatic, gastrointestinal, opthalmologic, hematologic,or psychiatric disease or disorder, or any uncontrolled medical illness.
Arms & Interventions
Substudy 2: Group 2
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
Intervention: ABBV-157
Substudy 2: Group 2
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
Intervention: Placebo for ABBV-157
Substudy 2: Group 1
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
Intervention: ABBV-157
Substudy 2: Group 1
Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
Intervention: Placebo for ABBV-157
Substudy 1: Group 3
Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
Intervention: ABBV-157
Substudy 1: Group 3
Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
Intervention: Placebo for ABBV-157
Substudy 1: Group 2
Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
Intervention: ABBV-157
Substudy 1: Group 2
Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
Intervention: Placebo for ABBV-157
Substudy 1: Group 1
Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
Intervention: ABBV-157
Substudy 1: Group 1
Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14
Intervention: Placebo for ABBV-157
Outcomes
Primary Outcomes
Substudy 2: Trough Concentration (Ctrough) of ABBV-157
Time Frame: Up to approximately 28 days
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Substudy 1: AUC0-24 Post-dose of ABBV-157
Time Frame: Day 1
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Substudy 1: Volume of Distribution (Vβ/F)
Time Frame: Day 14
Volume of Distribution (Vβ/F) of ABBV-157
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Time Frame: Day 14
Apparent Terminal phase elimination rate constant (β or Beta)
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Time Frame: Day 14
Fraction excreted unchanged in urine (fe)
Substudy 1: Apparent Renal Clearance (CLR)
Time Frame: Day 14
Apparent Renal Clearance (CLR) of ABBV-157
Substudy 1: Accumulation Ratio for AUCtau
Time Frame: Up to approximately 14 days
Accumulation Ratio for AUCtau
Substudy 2: Apparent Oral Clearance (CL/F)
Time Frame: Day 28
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Substudy 2: Volume of Distribution (Vβ/F)
Time Frame: Day 28
Volume of Distribution (Vβ/F) of ABBV-157
Substudy 1: Cmax of ABBV-157
Time Frame: Up to approximately 14 days
Maximum observed plasma concentration (Cmax) of ABBV-157
Substudy 1: Tmax of ABBV-157
Time Frame: Up to approximately 14 days
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Substudy 1: Trough Concentration (Ctrough) of ABBV-157
Time Frame: Up to approximately 14 days
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Substudy 1: Apparent Oral Clearance (CL/F)
Time Frame: Day 14
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Substudy 1: Elimination Half-Life (t1/2)
Time Frame: Day 14
Terminal phase elimination half-life (t1/2) of ABBV-157
Substudy 1: AUCtau of ABBV-157
Time Frame: Up to approximately 14 days
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
Substudy 2: Cmax of ABBV-157
Time Frame: Up to approximately 28 days
Maximum observed plasma concentration (Cmax) of ABBV-157
Substudy 2: Tmax of ABBV-157
Time Frame: Up to approximately 28 days
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Substudy 2: AUC0-24 Post-dose of ABBV-157
Time Frame: Day 1
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.
Substudy 2: Elimination Half-Life (t1/2)
Time Frame: Day 28
Terminal phase elimination half-life (t1/2) of ABBV-157
Substudy 2: Accumulation ratio for Cmax
Time Frame: Up to approximately 28 days
Accumulation ratio for Cmax
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Time Frame: Day 28
Apparent Terminal phase elimination rate constant (β or Beta)
Substudy 2: Accumulation Ratio for AUCtau
Time Frame: Up to approximately 28 days
Accumulation Ratio for AUCtau
Substudy 1: Accumulation ratio for Cmax
Time Frame: Up to approximately 14 days
Accumulation ratio for Cmax
Substudy 2: AUCtau of ABBV-157
Time Frame: Day 28
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline
Time Frame: Up to approximately 28 days
SAPS is a self-assessment questionnaire of psoriasis symptoms.
Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline
Time Frame: Up to approximately 28 days
Psoriasis Area and Severity Index (PASI) score quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 58
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.