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

Psoriasis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062618
• Other study ID #: PRCL-SMAD
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2017
• Last updated: March 6, 2018
• Start date: February 20, 2017
• Est. completion date: February 8, 2018

Study information

• Verified date: March 2018
• Source: PRCL Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• PRCL-02
Oral tablet(s) administered with water
• Placebo Oral Tablet
Administered with water

Locations

Country	Name	City	State
Canada	Lynde Centre for Dermatology	Markham	Ontario
Canada	Centre de Dermatologie et Chirurgie Dermatologique	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	InVentiv Health	Quebec
Canada	Dr. Chih-ho Hong Medical Inc	Surrey	British Columbia
Canada	K Papp Clinical Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
PRCL Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with Physical Examination Findings in Part A	Abnormal physical exam findings	Baseline up to approximately 45 days
Secondary	Number of participants with Physical Examination Findings in Part B	Abnormal physical exam findings	Baseline up to approximately 50 days
Secondary	Number of participants with Physical Examination Findings in Part C	Abnormal physical exam findings	Baseline up to approximately 73 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum Observed Drug Concentration (Cmax) in Part A	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 29 days
Secondary	Maximum Observed Drug Concentration (Cmax) in Part B	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 33 days
Secondary	Maximum Observed Drug Concentration (Cmax) in Part C	Maximum observed plasma concentration of PRCL-02	Baseline up to approximately 31 days
Secondary	Time to Maximum Drug Concentration (Tmax) in Part A	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 29 days
Secondary	Time to Maximum Drug Concentration (Tmax) in Part B	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 33 days
Secondary	Time to Maximum Drug Concentration (Tmax) in Part C	Time to maximum plasma concentration of PRCL-02	Baseline up to approximately 31 days
Secondary	Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-8) in Part A	Area under the plasma concentration-time curve from time 0 to infinity	Baseline up to approximately 29 days
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Elimination Rate (Ke)	Elimination rate of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Accumulation Ratio	Accumulation ratio of PRCL-02	Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)