PsoriasisPhase 1NCT03062618
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
A Phase 1 study testing PRCL-02 in people with Psoriasis, run by PRCL Research Inc. at 6 sites in Canada.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- PRCL-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 6 sitesCanada
- Study dates
- 20 Feb 2017to 8 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Lynde Centre for Dermatology
Markham, Ontario, L3P 1X2
Centre de Dermatologie et Chirurgie Dermatologique
Montreal, Quebec, H3Z 2S6
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
InVentiv Health
Québec, G1P 0A2
Dr. Chih-ho Hong Medical Inc
Surrey, British Columbia, V3R 6A7
K Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
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)
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)
- Conditions
- Psoriasis
- Being tested
- PRCL-02, Placebo Oral Tablet
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRCL-02Drug
Oral tablet(s) administered with water
Placebo Oral TabletDrug
Administered with water
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Dose | Experimental | Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg) Receives: Drug: PRCL-02 |
| Part A: Single Dose (Placebo) | Placebo comparator | Two escalating sequences of matching placebo oral tablets, in 3 periods Receives: Drug: Placebo Oral Tablet |
| Part B: Multiple Dose | Experimental | Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels Receives: Drug: PRCL-02 |
| Part B: Multiple Dose (Placebo) | Placebo comparator | Multiple oral doses of placebo for 28 days, at matching dose levels Receives: Drug: Placebo Oral Tablet |
| Part C: Multiple Dose | Experimental | Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels Receives: Drug: PRCL-02 |
| Part C: Multiple Dose (Placebo) | Placebo comparator | Multiple oral doses of placebo for 28 days, at matching dose levels Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline up to approximately 73 days
Secondary outcomes (33)
Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A
Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to approximately 73 days
Number of participants with Physical Examination Findings in Part A
Abnormal physical exam findings
Measured: Baseline up to approximately 45 days
Number of participants with Physical Examination Findings in Part B
Abnormal physical exam findings
Measured: Baseline up to approximately 50 days
Number of participants with Physical Examination Findings in Part C
Abnormal physical exam findings
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to approximately 73 days
Maximum Observed Drug Concentration (Cmax) in Part A
Maximum observed plasma concentration of PRCL-02
Measured: Baseline up to approximately 29 days
Maximum Observed Drug Concentration (Cmax) in Part B
Maximum observed plasma concentration of PRCL-02
Measured: Baseline up to approximately 33 days
Maximum Observed Drug Concentration (Cmax) in Part C
Maximum observed plasma concentration of PRCL-02
Measured: Baseline up to approximately 31 days
Time to Maximum Drug Concentration (Tmax) in Part A
Time to maximum plasma concentration of PRCL-02
Measured: Baseline up to approximately 29 days
Time to Maximum Drug Concentration (Tmax) in Part B
Time to maximum plasma concentration of PRCL-02
Measured: Baseline up to approximately 33 days
Time to Maximum Drug Concentration (Tmax) in Part C
Time to maximum plasma concentration of PRCL-02
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline up to approximately 31 days
Minimum or Trough Concentration (Cmin)
Minimum or trough concentration of PRCL-02
Measured: 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
Measured: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Elimination Rate (Ke)
Elimination rate of PRCL-02
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Accumulation Ratio
Accumulation ratio of PRCL-02
Measured: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start20 Feb 2017
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PRCL Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Email PRCL@Choruspharma.com, Study director, PRCL Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062618
- Sponsor's protocol ID
- PRCL-SMAD
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03062618
- Acronym / sponsor ID
- PRCL-SMAD
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PRCL Research Inc.University, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Dose | Experimental | Drug: PRCL-02Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg) |
| Part A: Single Dose (Placebo) | Placebo comparator | Drug: Placebo Oral TabletTwo escalating sequences of matching placebo oral tablets, in 3 periods |
| Part B: Multiple Dose | Experimental | Drug: PRCL-02Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels |
| Part B: Multiple Dose (Placebo) | Placebo comparator | Drug: Placebo Oral TabletMultiple oral doses of placebo for 28 days, at matching dose levels |
| Part C: Multiple Dose | Experimental | Drug: PRCL-02Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels |
| Part C: Multiple Dose (Placebo) | Placebo comparator | Drug: Placebo Oral TabletMultiple oral doses of placebo for 28 days, at matching dose levels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRCL-02Oral tablet(s) administered with water | Drug | Part A: Single Dose, Part B: Multiple Dose, Part C: Multiple Dose |
| Placebo Oral TabletAdministered with water | Drug | Part A: Single Dose (Placebo), Part B: Multiple Dose (Placebo), Part C: Multiple Dose (Placebo) |
Primary outcome
Number of Participants with One or More Serious Adverse Events (Part A)
Time frame: 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)
Time frame: 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)
Time frame: Baseline up to approximately 73 days
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
33 secondary outcomes
Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A
Time frame: Baseline up to 24 hours post-dose on day 2
Change in Baseline in Triplicate 12-lead ECG in Part B
Time frame: Baseline up to 24 hours post-dose on day 6
Change in Baseline in Triplicate 12-lead ECG in Part C
Time frame: Baseline up to approximately day 28
Change from Baseline in Single 12-Lead ECG in Part A
Time frame: Baseline up to approximately 45 days
Change from Baseline in Single 12-Lead ECG in Part B
Time frame: Baseline up to approximately 50 days
Change from Baseline in Single 12-Lead ECG in Part C
Time frame: Baseline up to approximately 73 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part A
Time frame: Baseline up to approximately 45 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part B
Time frame: Baseline up to approximately 50 days
Number of Participants With Clinically Significant Changes in Vital Signs in Part C
Time frame: Baseline up to approximately 73 days
Number of participants with Physical Examination Findings in Part A
Time frame: Baseline up to approximately 45 days
Number of participants with Physical Examination Findings in Part B
Time frame: Baseline up to approximately 50 days
Number of participants with Physical Examination Findings in Part C
Time frame: Baseline up to approximately 73 days
Number of participants with Laboratory Test Results outside of reference range in Part A
Time frame: Baseline up to approximately 45 days
Number of participants with Laboratory Test Results outside of reference range in Part B
Time frame: Baseline up to approximately 50 days
Number of participants with Laboratory Test Results outside of reference range in Part C
Time frame: Baseline up to approximately 73 days
Maximum Observed Drug Concentration (Cmax) in Part A
Time frame: Baseline up to approximately 29 days
Maximum Observed Drug Concentration (Cmax) in Part B
Time frame: Baseline up to approximately 33 days
Maximum Observed Drug Concentration (Cmax) in Part C
Time frame: Baseline up to approximately 31 days
Time to Maximum Drug Concentration (Tmax) in Part A
Time frame: Baseline up to approximately 29 days
Time to Maximum Drug Concentration (Tmax) in Part B
Time frame: Baseline up to approximately 33 days
Time to Maximum Drug Concentration (Tmax) in Part C
Time frame: Baseline up to approximately 31 days
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A
Time frame: Baseline up to approximately 29 days
Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B
Time frame: Baseline up to approximately 33 days
Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C
Time frame: Baseline up to approximately 31 days
Minimum or Trough Concentration (Cmin)
Time frame: 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 frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Elimination Rate (Ke)
Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Terminal Elimination Half-Life (t1/2)
Time frame: 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)
Time frame: 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)
Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Apparent Clearance (CL/F)
Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Apparent Volume of Distribution (Vd/F)
Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Accumulation Ratio
Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email PRCL@Choruspharma.com study director
PRCL Research Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRCL-02 in people with Psoriasis, run by PRCL Research Inc. at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Events (Part A) (time frame: Baseline up to approximately 45 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.