Back to resultsA Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
PRCL-02
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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)
Sites / Locations
- Dr. Chih-ho Hong Medical Inc
- Lynde Centre for Dermatology
- SKiN Centre for Dermatology
- K Papp Clinical Research
- Centre de Dermatologie et Chirurgie Dermatologique
- InVentiv Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Part A: Single Dose
Part A: Single Dose (Placebo)
Part B: Multiple Dose
Part B: Multiple Dose (Placebo)
Part C: Multiple Dose
Part C: Multiple Dose (Placebo)
Arm Description
Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)
Two escalating sequences of matching placebo oral tablets, in 3 periods
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Multiple oral doses of placebo for 28 days, at matching dose levels
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Multiple oral doses of placebo for 28 days, at matching dose levels
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A
Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)
Change in Baseline in Triplicate 12-lead ECG in Part B
Mean change from baseline in triplicate 12-lead ECG
Change in Baseline in Triplicate 12-lead ECG in Part C
Mean change from baseline in triplicate 12-lead ECG
Change from Baseline in Single 12-Lead ECG in Part A
Mean change from baseline in single 12-lead ECG
Change from Baseline in Single 12-Lead ECG in Part B
Mean change from baseline in single 12-lead ECG
Change from Baseline in Single 12-Lead ECG in Part C
Mean change from baseline in single 12-lead ECG
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Number of Participants With Clinically Significant Changes in Vital Signs in Part B
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Number of Participants With Clinically Significant Changes in Vital Signs in Part C
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Number of participants with Physical Examination Findings in Part A
Abnormal physical exam findings
Number of participants with Physical Examination Findings in Part B
Abnormal physical exam findings
Number of participants with Physical Examination Findings in Part C
Abnormal physical exam findings
Number of participants with Laboratory Test Results outside of reference range in Part A
Laboratory results outside of reference range
Number of participants with Laboratory Test Results outside of reference range in Part B
Laboratory results outside of reference range
Number of participants with Laboratory Test Results outside of reference range in Part C
Laboratory results outside of reference range
Maximum Observed Drug Concentration (Cmax) in Part A
Maximum observed plasma concentration of PRCL-02
Maximum Observed Drug Concentration (Cmax) in Part B
Maximum observed plasma concentration of PRCL-02
Maximum Observed Drug Concentration (Cmax) in Part C
Maximum observed plasma concentration of PRCL-02
Time to Maximum Drug Concentration (Tmax) in Part A
Time to maximum plasma concentration of PRCL-02
Time to Maximum Drug Concentration (Tmax) in Part B
Time to maximum plasma concentration of PRCL-02
Time to Maximum Drug Concentration (Tmax) in Part C
Time to maximum plasma concentration of PRCL-02
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
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)
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)
Minimum or Trough Concentration (Cmin)
Minimum or trough concentration of PRCL-02
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
Elimination Rate (Ke)
Elimination rate of PRCL-02
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life of PRCL-02
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
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
Apparent Clearance (CL/F)
Apparent clearance of PRCL-02
Apparent Volume of Distribution (Vd/F)
Apparent volume of distribution of PRCL-02
Accumulation Ratio
Accumulation ratio of PRCL-02
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03062618
Brief Title
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PRCL Research Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: Single Dose
Arm Type
Experimental
Arm Description
Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)
Arm Title
Part A: Single Dose (Placebo)
Arm Type
Placebo Comparator
Arm Description
Two escalating sequences of matching placebo oral tablets, in 3 periods
Arm Title
Part B: Multiple Dose
Arm Type
Experimental
Arm Description
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Arm Title
Part B: Multiple Dose (Placebo)
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of placebo for 28 days, at matching dose levels
Arm Title
Part C: Multiple Dose
Arm Type
Experimental
Arm Description
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Arm Title
Part C: Multiple Dose (Placebo)
Arm Type
Placebo Comparator
Arm Description
Multiple oral doses of placebo for 28 days, at matching dose levels
Intervention Type
Drug
Intervention Name(s)
PRCL-02
Intervention Description
Oral tablet(s) administered with water
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Administered with water
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Events (Part A)
Description
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
Time Frame
Baseline up to approximately 45 days
Title
Number of Participants with One or More Serious Adverse Events (Part B)
Description
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
Time Frame
Baseline up to approximately 50 days
Title
Number of Participants with One or More Serious Adverse Events (Part C)
Description
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
Time Frame
Baseline up to approximately 73 days
Secondary Outcome Measure Information:
Title
Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A
Description
Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)
Time Frame
Baseline up to 24 hours post-dose on day 2
Title
Change in Baseline in Triplicate 12-lead ECG in Part B
Description
Mean change from baseline in triplicate 12-lead ECG
Time Frame
Baseline up to 24 hours post-dose on day 6
Title
Change in Baseline in Triplicate 12-lead ECG in Part C
Description
Mean change from baseline in triplicate 12-lead ECG
Time Frame
Baseline up to approximately day 28
Title
Change from Baseline in Single 12-Lead ECG in Part A
Description
Mean change from baseline in single 12-lead ECG
Time Frame
Baseline up to approximately 45 days
Title
Change from Baseline in Single 12-Lead ECG in Part B
Description
Mean change from baseline in single 12-lead ECG
Time Frame
Baseline up to approximately 50 days
Title
Change from Baseline in Single 12-Lead ECG in Part C
Description
Mean change from baseline in single 12-lead ECG
Time Frame
Baseline up to approximately 73 days
Title
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Description
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Time Frame
Baseline up to approximately 45 days
Title
Number of Participants With Clinically Significant Changes in Vital Signs in Part B
Description
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Time Frame
Baseline up to approximately 50 days
Title
Number of Participants With Clinically Significant Changes in Vital Signs in Part C
Description
Respiration Rate, Heart Rate, Blood Pressure, Temperature
Time Frame
Baseline up to approximately 73 days
Title
Number of participants with Physical Examination Findings in Part A
Description
Abnormal physical exam findings
Time Frame
Baseline up to approximately 45 days
Title
Number of participants with Physical Examination Findings in Part B
Description
Abnormal physical exam findings
Time Frame
Baseline up to approximately 50 days
Title
Number of participants with Physical Examination Findings in Part C
Description
Abnormal physical exam findings
Time Frame
Baseline up to approximately 73 days
Title
Number of participants with Laboratory Test Results outside of reference range in Part A
Description
Laboratory results outside of reference range
Time Frame
Baseline up to approximately 45 days
Title
Number of participants with Laboratory Test Results outside of reference range in Part B
Description
Laboratory results outside of reference range
Time Frame
Baseline up to approximately 50 days
Title
Number of participants with Laboratory Test Results outside of reference range in Part C
Description
Laboratory results outside of reference range
Time Frame
Baseline up to approximately 73 days
Title
Maximum Observed Drug Concentration (Cmax) in Part A
Description
Maximum observed plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 29 days
Title
Maximum Observed Drug Concentration (Cmax) in Part B
Description
Maximum observed plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 33 days
Title
Maximum Observed Drug Concentration (Cmax) in Part C
Description
Maximum observed plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 31 days
Title
Time to Maximum Drug Concentration (Tmax) in Part A
Description
Time to maximum plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 29 days
Title
Time to Maximum Drug Concentration (Tmax) in Part B
Description
Time to maximum plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 33 days
Title
Time to Maximum Drug Concentration (Tmax) in Part C
Description
Time to maximum plasma concentration of PRCL-02
Time Frame
Baseline up to approximately 31 days
Title
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A
Description
Area under the plasma concentration-time curve from time 0 to infinity
Time Frame
Baseline up to approximately 29 days
Title
Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B
Description
Area under the plasma concentration-time curve during the dosing interval of 24 hours (24h)
Time Frame
Baseline up to approximately 33 days
Title
Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C
Description
Area under the plasma concentration-time curve during the dosing interval (24h)
Time Frame
Baseline up to approximately 31 days
Title
Minimum or Trough Concentration (Cmin)
Description
Minimum or trough concentration of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag)
Description
Time delay between administration of PRCL-02 and first observed plasma concentration
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Elimination Rate (Ke)
Description
Elimination rate of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Terminal Elimination Half-Life (t1/2)
Description
Terminal elimination half-life of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24)
Description
Area under the plasma concentration time curve from time zero to 24 hours
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t)
Description
Area under the plasma concentration time curve from time zero to the last observed time point
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Apparent Clearance (CL/F)
Description
Apparent clearance of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Apparent Volume of Distribution (Vd/F)
Description
Apparent volume of distribution of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Title
Accumulation Ratio
Description
Accumulation ratio of PRCL-02
Time Frame
Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email PRCL@Choruspharma.com
Organizational Affiliation
PRCL Research Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Chih-ho Hong Medical Inc
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Lynde Centre for Dermatology
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
K Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Centre de Dermatologie et Chirurgie Dermatologique
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada
Facility Name
InVentiv Health
City
Quebec
ZIP/Postal Code
G1P 0A2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
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