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

  Purpose

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)

Condition Intervention Phase
Psoriasis Drug: PRCL-02 Drug: Placebo Oral Tablet Phase 1

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by PRCL Research Inc.:

Primary Outcome Measures:

  • 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

Secondary Outcome Measures:

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Number of participants with Physical Examination Findings in Part A [ Time Frame: Baseline up to approximately 45 days ]
    Abnormal physical exam findings

  • Number of participants with Physical Examination Findings in Part B [ Time Frame: Baseline up to approximately 50 days ]
    Abnormal physical exam findings

  • Number of participants with Physical Examination Findings in Part C [ Time Frame: Baseline up to approximately 73 days ]
    Abnormal physical exam findings

  • 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

  • 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

  • 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

  • Maximum Observed Drug Concentration (Cmax) in Part A [ Time Frame: Baseline up to approximately 29 days ]
    Maximum observed plasma concentration of PRCL-02

  • Maximum Observed Drug Concentration (Cmax) in Part B [ Time Frame: Baseline up to approximately 33 days ]
    Maximum observed plasma concentration of PRCL-02

  • Maximum Observed Drug Concentration (Cmax) in Part C [ Time Frame: Baseline up to approximately 31 days ]
    Maximum observed plasma concentration of PRCL-02

  • 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

  • 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

  • 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

  • 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

  • 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)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Estimated Enrollment:50
Actual Study Start Date:February 20, 2017
Estimated Study Completion Date:January 9, 2018
Estimated Primary Completion Date:January 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: Single Dose

Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)
Drug: PRCL-02

Oral tablet(s) administered with water
Placebo Comparator: Part A: Single Dose (Placebo)

Two escalating sequences of matching placebo oral tablets, in 3 periods
Drug: Placebo Oral Tablet

Administered with water
Experimental: Part B: Multiple Dose

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Drug: PRCL-02

Oral tablet(s) administered with water
Placebo Comparator: Part B: Multiple Dose (Placebo)

Multiple oral doses of placebo for 28 days, at matching dose levels
Drug: Placebo Oral Tablet

Administered with water
Experimental: Part C: Multiple Dose

Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
Drug: PRCL-02

Oral tablet(s) administered with water
Placebo Comparator: Part C: Multiple Dose (Placebo)

Multiple oral doses of placebo for 28 days, at matching dose levels
Drug: Placebo Oral Tablet

Administered with water

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