A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis

Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: PRCL-02; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1P 0A2
    • InVentiv Health
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Lynde Centre for Dermatology
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K Papp Clinical Research
  • Quebec
    • Montreal, Quebec, Canada, H3Z 2S6
      • Centre de Dermatologie et Chirurgie Dermatologique

Participation Criteria

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:

Parts A and B

• Be 18 to 55 years old
• Be healthy with absence of clinically significant illness
• Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
• Female participants must be postmenopausal or surgically sterile
• Have venous access sufficient for blood sampling
• Be a non-smoker

Part C

• Be 18 to 75 years old
• Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
• Have at least 2 evaluable plaques located in at least 2 body regions

Exclusion Criteria:

Parts A and B

• Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
• Hepatic or renal impairment
• Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
• Female participants who are pregnant or breast feeding
• Recent or ongoing infection
• History of alcohol or drug abuse
• Current or recent enrollment in a clinical trial judged not compatible with this study

Part C

• Have highly active psoriatic arthritis
• Have pustular, erythrodermic and/or guttate forms of psoriasis
• Have had a clinically-significant flare of psoriasis during the last 12 weeks
• Currently or recently taking certain prescribed therapies for psoriasis
• Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: Single Dose; Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)	Drug: PRCL-02; Oral tablet(s) administered with water
PLACEBO_COMPARATOR: Part A: Single Dose (Placebo); Two escalating sequences of matching placebo oral tablets, in 3 periods	Drug: Placebo Oral Tablet; Administered with water
EXPERIMENTAL: Part B: Multiple Dose; Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels	Drug: PRCL-02; Oral tablet(s) administered with water
PLACEBO_COMPARATOR: Part B: Multiple Dose (Placebo); Multiple oral doses of placebo for 28 days, at matching dose levels	Drug: Placebo Oral Tablet; Administered with water
EXPERIMENTAL: Part C: Multiple Dose; Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels	Drug: PRCL-02; Oral tablet(s) administered with water
PLACEBO_COMPARATOR: Part C: Multiple Dose (Placebo); Multiple oral doses of placebo for 28 days, at matching dose levels	Drug: Placebo Oral Tablet; Administered with water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Events (Part A)	Number of participants with a serious adverse event, regardless of causality, by dose and treatment	Baseline up to approximately 45 days
Number of Participants with One or More Serious Adverse Events (Part B)	Number of participants with a serious adverse event, regardless of causality, by dose and treatment	Baseline up to approximately 50 days
Number of Participants with One or More Serious Adverse Events (Part C)	Number of participants with a serious adverse event, regardless of causality, by dose and treatment	Baseline up to approximately 73 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A	Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)	Baseline up to 24 hours post-dose on day 2
Change in Baseline in Triplicate 12-lead ECG in Part B	Mean change from baseline in triplicate 12-lead ECG	Baseline up to 24 hours post-dose on day 6
Change in Baseline in Triplicate 12-lead ECG in Part C	Mean change from baseline in triplicate 12-lead ECG	Baseline up to approximately day 28
Change from Baseline in Single 12-Lead ECG in Part A	Mean change from baseline in single 12-lead ECG	Baseline up to approximately 45 days
Change from Baseline in Single 12-Lead ECG in Part B	Mean change from baseline in single 12-lead ECG	Baseline up to approximately 50 days
Change from Baseline in Single 12-Lead ECG in Part C	Mean change from baseline in single 12-lead ECG	Baseline up to approximately 73 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part A	Respiration Rate, Heart Rate, Blood Pressure, Temperature	Baseline up to approximately 45 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part B	Respiration Rate, Heart Rate, Blood Pressure, Temperature	Baseline up to approximately 50 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part C	Respiration Rate, Heart Rate, Blood Pressure, Temperature	Baseline up to approximately 73 days
Number of participants with Physical Examination Findings in Part A	Abnormal physical exam findings	Baseline up to approximately 45 days
Number of participants with Physical Examination Findings in Part B	Abnormal physical exam findings	Baseline up to approximately 50 days
Number of participants with Physical Examination Findings in Part C	Abnormal physical exam findings	Baseline up to approximately 73 days
Number of participants with Laboratory Test Results outside of reference range in Part A	Laboratory results outside of reference range	Baseline up to approximately 45 days
Number of participants with Laboratory Test Results outside of reference range in Part B	Laboratory results outside of reference range	Baseline up to approximately 50 days
Number of participants with Laboratory Test Results outside of reference range in Part C	Laboratory results outside of reference range	Baseline up to approximately 73 days
Maximum Observed Drug Concentration (Cmax) in Part A	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 29 days
Maximum Observed Drug Concentration (Cmax) in Part B	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 33 days
Maximum Observed Drug Concentration (Cmax) in Part C	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 31 days
Time to Maximum Drug Concentration (Tmax) in Part A	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 29 days
Time to Maximum Drug Concentration (Tmax) in Part B	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 33 days
Time to Maximum Drug Concentration (Tmax) in Part C	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 31 days
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A	Area under the plasma concentration-time curve from time 0 to infinity	Baseline up to approximately 29 days
Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B	Area under the plasma concentration-time curve during the dosing interval of 24 hours (24h)	Baseline up to approximately 33 days
Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C	Area under the plasma concentration-time curve during the dosing interval (24h)	Baseline up to approximately 31 days
Minimum or Trough Concentration (Cmin)	Minimum or trough concentration of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag)	Time delay between administration of PRCL-02 and first observed plasma concentration	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Elimination Rate (Ke)	Elimination rate of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Terminal Elimination Half-Life (t1/2)	Terminal elimination half-life of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24)	Area under the plasma concentration time curve from time zero to 24 hours	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t)	Area under the plasma concentration time curve from time zero to the last observed time point	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Apparent Clearance (CL/F)	Apparent clearance of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Apparent Volume of Distribution (Vd/F)	Apparent volume of distribution of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Accumulation Ratio	Accumulation ratio of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

Collaborators and Investigators

• Sponsor: PRCL Research Inc.
• Investigators: Study Director: Email PRCL@Choruspharma.com, PRCL Research Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2017
• Primary Completion (ACTUAL): February 8, 2018
• Study Completion (ACTUAL): February 8, 2018

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PRCL-SMAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes