Psoriasis
Conditions
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)
Interventions
DRUGPRCL-02
Oral tablet(s) administered with water
DRUGPlacebo Oral Tablet
Administered with water
Sponsors
PRCL Research Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (Part A) | Baseline up to approximately 45 days | 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) | Baseline up to approximately 50 days | 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) | Baseline up to approximately 73 days | Number of participants with a serious adverse event, regardless of causality, by dose and treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A | Baseline up to 24 hours post-dose on day 2 | Mean change from baseline in triplicate 12-lead electrocardiogram (ECG) |
| Change from Baseline in Single 12-Lead ECG in Part B | Baseline up to approximately 50 days | Mean change from baseline in single 12-lead ECG |
| Change from Baseline in Single 12-Lead ECG in Part C | Baseline up to approximately 73 days | Mean change from baseline in single 12-lead ECG |
| Number of Participants With Clinically Significant Changes in Vital Signs in Part A | Baseline up to approximately 45 days | Respiration Rate, Heart Rate, Blood Pressure, Temperature |
| Number of Participants With Clinically Significant Changes in Vital Signs in Part B | Baseline up to approximately 50 days | Respiration Rate, Heart Rate, Blood Pressure, Temperature |
| Number of Participants With Clinically Significant Changes in Vital Signs in Part C | Baseline up to approximately 73 days | Respiration Rate, Heart Rate, Blood Pressure, Temperature |
| Number of participants with Physical Examination Findings in Part A | Baseline up to approximately 45 days | Abnormal physical exam findings |
| Number of participants with Physical Examination Findings in Part B | Baseline up to approximately 50 days | Abnormal physical exam findings |
| Number of participants with Physical Examination Findings in Part C | Baseline up to approximately 73 days | Abnormal physical exam findings |
| Number of participants with Laboratory Test Results outside of reference range in Part A | Baseline up to approximately 45 days | Laboratory results outside of reference range |
| Number of participants with Laboratory Test Results outside of reference range in Part B | Baseline up to approximately 50 days | Laboratory results outside of reference range |
| Number of participants with Laboratory Test Results outside of reference range in Part C | Baseline up to approximately 73 days | Laboratory results outside of reference range |
| Maximum Observed Drug Concentration (Cmax) in Part A | Baseline up to approximately 29 days | Maximum observed plasma concentration of PRCL-02 |
| Maximum Observed Drug Concentration (Cmax) in Part B | Baseline up to approximately 33 days | Maximum observed plasma concentration of PRCL-02 |
| Maximum Observed Drug Concentration (Cmax) in Part C | Baseline up to approximately 31 days | Maximum observed plasma concentration of PRCL-02 |
| Change from Baseline in Single 12-Lead ECG in Part A | Baseline up to approximately 45 days | Mean change from baseline in single 12-lead ECG |
| Time to Maximum Drug Concentration (Tmax) in Part B | Baseline up to approximately 33 days | Time to maximum plasma concentration of PRCL-02 |
| Time to Maximum Drug Concentration (Tmax) in Part C | Baseline up to approximately 31 days | Time to maximum plasma concentration of PRCL-02 |
| Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A | Baseline up to approximately 29 days | 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 | Baseline up to approximately 33 days | 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 | Baseline up to approximately 31 days | Area under the plasma concentration-time curve during the dosing interval (24h) |
| Minimum or Trough Concentration (Cmin) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Minimum or trough concentration of PRCL-02 |
| Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Time delay between administration of PRCL-02 and first observed plasma concentration |
| Elimination Rate (Ke) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Elimination rate of PRCL-02 |
| Terminal Elimination Half-Life (t1/2) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Terminal elimination half-life of PRCL-02 |
| Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24) | 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 |
| Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t) | 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 |
| Apparent Clearance (CL/F) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Apparent clearance of PRCL-02 |
| Apparent Volume of Distribution (Vd/F) | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Apparent volume of distribution of PRCL-02 |
| Accumulation Ratio | Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C) | Accumulation ratio of PRCL-02 |
| Time to Maximum Drug Concentration (Tmax) in Part A | Baseline up to approximately 29 days | Time to maximum plasma concentration of PRCL-02 |
| Change in Baseline in Triplicate 12-lead ECG in Part B | Baseline up to 24 hours post-dose on day 6 | Mean change from baseline in triplicate 12-lead ECG |
| Change in Baseline in Triplicate 12-lead ECG in Part C | Baseline up to approximately day 28 | Mean change from baseline in triplicate 12-lead ECG |
Countries
Canada
Outcome results
None listed