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Completed

NCT Number: NCT03062618

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

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)

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Chih-ho Hong Medical Inc, Surrey, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PRCL-02

Drug

Oral tablet(s) administered with water

Placebo oral tablet

Drug

Administered with water

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A

    Time frame: Baseline up to 24 hours post-dose on day 2

    Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)

  2. Change in Baseline in Triplicate 12-lead ECG in Part B

    Time frame: Baseline up to 24 hours post-dose on day 6

    Mean change from baseline in triplicate 12-lead ECG

  3. Change in Baseline in Triplicate 12-lead ECG in Part C

    Time frame: Baseline up to approximately day 28

    Mean change from baseline in triplicate 12-lead ECG

  4. Change from Baseline in Single 12-Lead ECG in Part A

    Time frame: Baseline up to approximately 45 days

    Mean change from baseline in single 12-lead ECG

  5. Change from Baseline in Single 12-Lead ECG in Part B

    Time frame: Baseline up to approximately 50 days

    Mean change from baseline in single 12-lead ECG

  6. Change from Baseline in Single 12-Lead ECG in Part C

    Time frame: Baseline up to approximately 73 days

    Mean change from baseline in single 12-lead ECG

  7. Number of Participants With Clinically Significant Changes in Vital Signs in Part A

    Time frame: Baseline up to approximately 45 days

    Respiration Rate, Heart Rate, Blood Pressure, Temperature

  8. Number of Participants With Clinically Significant Changes in Vital Signs in Part B

    Time frame: Baseline up to approximately 50 days

    Respiration Rate, Heart Rate, Blood Pressure, Temperature

  9. Number of Participants With Clinically Significant Changes in Vital Signs in Part C

    Time frame: Baseline up to approximately 73 days

    Respiration Rate, Heart Rate, Blood Pressure, Temperature

  10. Number of participants with Physical Examination Findings in Part A

    Time frame: Baseline up to approximately 45 days

    Abnormal physical exam findings

  11. Number of participants with Physical Examination Findings in Part B

    Time frame: Baseline up to approximately 50 days

    Abnormal physical exam findings

  12. Number of participants with Physical Examination Findings in Part C

    Time frame: Baseline up to approximately 73 days

    Abnormal physical exam findings

  13. Number of participants with Laboratory Test Results outside of reference range in Part A

    Time frame: Baseline up to approximately 45 days

    Laboratory results outside of reference range

  14. Number of participants with Laboratory Test Results outside of reference range in Part B

    Time frame: Baseline up to approximately 50 days

    Laboratory results outside of reference range

  15. Number of participants with Laboratory Test Results outside of reference range in Part C

    Time frame: Baseline up to approximately 73 days

    Laboratory results outside of reference range

  16. Maximum Observed Drug Concentration (Cmax) in Part A

    Time frame: Baseline up to approximately 29 days

    Maximum observed plasma concentration of PRCL-02

  17. Maximum Observed Drug Concentration (Cmax) in Part B

    Time frame: Baseline up to approximately 33 days

    Maximum observed plasma concentration of PRCL-02

  18. Maximum Observed Drug Concentration (Cmax) in Part C

    Time frame: Baseline up to approximately 31 days

    Maximum observed plasma concentration of PRCL-02

  19. Time to Maximum Drug Concentration (Tmax) in Part A

    Time frame: Baseline up to approximately 29 days

    Time to maximum plasma concentration of PRCL-02

  20. Time to Maximum Drug Concentration (Tmax) in Part B

    Time frame: Baseline up to approximately 33 days

    Time to maximum plasma concentration of PRCL-02

  21. Time to Maximum Drug Concentration (Tmax) in Part C

    Time frame: Baseline up to approximately 31 days

    Time to maximum plasma concentration of PRCL-02

  22. 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 from time 0 to infinity

  23. 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 of 24 hours (24h)

  24. 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

    Area under the plasma concentration-time curve during the dosing interval (24h)

  25. Minimum or Trough Concentration (Cmin)

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Minimum or trough concentration of PRCL-02

  26. 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)

    Time delay between administration of PRCL-02 and first observed plasma concentration

  27. Elimination Rate (Ke)

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Elimination rate of PRCL-02

  28. Terminal Elimination Half-Life (t1/2)

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Terminal elimination half-life of PRCL-02

  29. 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 24 hours

  30. 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)

    Area under the plasma concentration time curve from time zero to the last observed time point

  31. Apparent Clearance (CL/F)

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Apparent clearance of PRCL-02

  32. Apparent Volume of Distribution (Vd/F)

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Apparent volume of distribution of PRCL-02

  33. Accumulation Ratio

    Time frame: Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)

    Accumulation ratio of PRCL-02

Sponsors and collaborators

Lead sponsor

PRCL Research Inc.

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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