Clinical trial NCT03062618: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: PRCL Research Inc.
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)


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)

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Events (Part A)
timeFrame: Baseline up to approximately 45 days
measure: Number of Participants with One or More Serious Adverse Events (Part B)
timeFrame: Baseline up to approximately 50 days
measure: Number of Participants with One or More Serious Adverse Events (Part C)
timeFrame: Baseline up to approximately 73 days
Secondary outcomes:
measure: Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A
timeFrame: Baseline up to 24 hours post-dose on day 2
measure: Change in Baseline in Triplicate 12-lead ECG in Part B
timeFrame: Baseline up to 24 hours post-dose on day 6
measure: Change in Baseline in Triplicate 12-lead ECG in Part C
timeFrame: Baseline up to approximately day 28
measure: Change from Baseline in Single 12-Lead ECG in Part A
timeFrame: Baseline up to approximately 45 days
measure: Change from Baseline in Single 12-Lead ECG in Part B
timeFrame: Baseline up to approximately 50 days
measure: Change from Baseline in Single 12-Lead ECG in Part C
timeFrame: Baseline up to approximately 73 days
measure: Number of Participants With Clinically Significant Changes in Vital Signs in Part A
timeFrame: Baseline up to approximately 45 days
measure: Number of Participants With Clinically Significant Changes in Vital Signs in Part B
timeFrame: Baseline up to approximately 50 days
measure: Number of Participants With Clinically Significant Changes in Vital Signs in Part C
timeFrame: Baseline up to approximately 73 days
measure: Number of participants with Physical Examination Findings in Part A
timeFrame: Baseline up to approximately 45 days
measure: Number of participants with Physical Examination Findings in Part B
timeFrame: Baseline up to approximately 50 days
measure: Number of participants with Physical Examination Findings in Part C
timeFrame: Baseline up to approximately 73 days
measure: Number of participants with Laboratory Test Results outside of reference range in Part A
timeFrame: Baseline up to approximately 45 days
measure: Number of participants with Laboratory Test Results outside of reference range in Part B
timeFrame: Baseline up to approximately 50 days
measure: Number of participants with Laboratory Test Results outside of reference range in Part C
timeFrame: Baseline up to approximately 73 days
measure: Maximum Observed Drug Concentration (Cmax) in Part A
timeFrame: Baseline up to approximately 29 days
measure: Maximum Observed Drug Concentration (Cmax) in Part B
timeFrame: Baseline up to approximately 33 days
measure: Maximum Observed Drug Concentration (Cmax) in Part C
timeFrame: Baseline up to approximately 31 days
measure: Time to Maximum Drug Concentration (Tmax) in Part A
timeFrame: Baseline up to approximately 29 days
measure: Time to Maximum Drug Concentration (Tmax) in Part B
timeFrame: Baseline up to approximately 33 days
measure: Time to Maximum Drug Concentration (Tmax) in Part C
timeFrame: Baseline up to approximately 31 days
measure: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A
timeFrame: Baseline up to approximately 29 days
measure: Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B
timeFrame: Baseline up to approximately 33 days
measure: Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C
timeFrame: Baseline up to approximately 31 days
measure: Minimum or Trough Concentration (Cmin)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Elimination Rate (Ke)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Terminal Elimination Half-Life (t1/2)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Apparent Clearance (CL/F)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
measure: Accumulation Ratio
timeFrame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc
state: British Columbia
city: Markham
country: Canada
facility: Lynde Centre for Dermatology
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Centre de Dermatologie et Chirurgie Dermatologique
state: Quebec
city: Quebec
country: Canada
facility: InVentiv Health
Study officials:
affiliation: PRCL Research Inc.
name: Email PRCL@Choruspharma.com
role: STUDY_DIRECTOR
References: