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Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03873324
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
Celon Pharma SA

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE December 20, 2018
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP. [ Time Frame: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B ]
    MTD is defined as the highest dose for which no more than 1 of the 6 treated volunteers (less than 1/3) exhibits dose limiting toxicity (DLT).
  • Safety and tolerability of IMP after single and multiple oral administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring. [ Time Frame: up to 14 days in PART A and up to 28 days in PART B of the study ]
    Participants are to be closely observed to assure maximal safety and to collect occurrence of all adverse events. All participants are to be monitored for clinically relevant changes in physical examination, vital signs, 12-lead ECG assessment and deviations from normal in clinical laboratory results (complete blood count, blood chemistry, urinalysis). To follow-up on all study participants telephone calls with a request for information regarding their health condition are to be made.
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Determination of maximum tolerated dose (MTD) or administration of the maximum dose provided in the protocol after single and multiple oral administration of IMP. [ Time Frame: up to 24 hours after single administration of IMP in PART A and up to 24 hours after the last IMP administration in PART B ]
    MTD is defined as the highest dose for which no more than 1 of the 6 treated volunteers (less than 1/3) exhibits dose limiting toxicity (DLT).
  • Safety and tolerability of IMP after single and multiple oral administration [ Time Frame: up to 14 days in PART A and up to 28 days in PART B of the study ]
    Participants during hospitalization are to be closely observed to assure maximal safety and to collect occurrence of all adverse event. To follow-up on all study participants telephone calls with a request for information regarding their health condition are to be made.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Cmax - maximum CPL500036 plasma concentration [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.
  • AUC(0-72) - area under the plasma concentration - time curve from time 0 to 72h after IMP administration for CPL500036 [ Time Frame: up to 72 hours after administration of IMP in PART A ]
    The AUC(0-72) is a measure of total plasma exposure to the drug from time point zero to 72 hours after IMP administration.
  • AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24h after IMP administration for CPL500036 [ Time Frame: up to 24 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 and 14 in PART B ]
    The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after IMP administration.
  • AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036 [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.
  • Tmax - time to reach maximum CPL500036 concentration [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.
  • Kel - terminal elimination rate constant [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    Kel is to be estimated via linear regression of time versus log of concentration.
  • T1/2 - The plasma elimination half-life for CPL500036 compound [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    T1/2 is to be calculated as 0.693/Kel.
  • C (1,t) - CPL500036 concentration [ Time Frame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B. ]
    The concentration of CPL500036 on day t before product administration.
  • C (Tmax, t) - CPL500036 concentration [ Time Frame: Determined on Day 2, 3, 4, 5, 6, 8, 9, 10, 11, 12 and 13 in PART B. ]
    The concentration on day t measured on time Tmax which was calculated in PART A of the study.
  • Amount of CPL500036 in each urine collection sample [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    It is to be calculated as CPL500036 concentration in urine sample times volume of urine collection.
  • Ae - total amount of CPL500036 excreted in urine [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    Ae is to be calculated as asymptote of the plot of the cumulative amount of drug excreted after each collection interval plotted against the median of the collection interval.
  • Clr - renal clearance [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    Clr is to be calculated by linear least squares regression analysis on semi-logarithmic transformed data (CLr = excretion rate/C).
  • Excretion rate [ Time Frame: up to 72 hours after administration of IMP in PART A and up to 24 hours after the IMP administration determined on Day 1, 7 in PART B and up to 72 hours after the last IMP administration on Day 14 in PART B ]
    Excretion rate calculated as = CLr/V x Dose x exp(-kt)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers
Official Title  ICMJE One Centre Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL500036 Compound in Healthy Volunteers
Brief Summary The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.
Detailed Description

This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.

PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.

PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.

Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Only PART B will be double-blind
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: CPL500036 compound
    IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).
  • Drug: Placebo
    matching placebo capsules
Study Arms  ICMJE
  • Experimental: CPL500036

    PART A: 7 cohorts are to receive single dose of IMP. Each participant is to take single dose of IMP. There is to be dose escalation between cohorts.

    PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts.

    Intervention: Drug: CPL500036 compound
  • Placebo Comparator: Placebo
    PART B: 2 Participants from 4 cohorts (total of 8 people) are to receive masking placebo capsules once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2019
Actual Primary Completion Date September 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Caucasian female or male,
  • Age: 18-55 years old, inclusive,
  • Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2,
  • Non-smoker and nonuser of tobacco products for at least 3 months before screening,
  • Physical examination without any clinically relevant abnormality,
  • Laboratory values not clinically significant,
  • Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

Exclusion Criteria:

  • Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
  • Any known significant current or past acute or chronic disease or condition,
  • Participation in other clinical trial within 90 days preceding the screening,
  • Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
  • Positive results from pregnancy test for female participants,
  • Lactation in women participants,
  • Hypotension or hypertension in medical history,
  • Long QT interval syndrome or is under the treatment with antiarrhythmic drugs,
  • Narcotic, alcohol addiction or abuse,
  • Participant who adhere to a special diet (e.g. low calories, vegetarian).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873324
Other Study ID Numbers  ICMJE 01PDE2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celon Pharma SA
Study Sponsor  ICMJE Celon Pharma SA
Collaborators  ICMJE National Center for Research and Development, Poland
Investigators  ICMJE Not Provided
PRS Account Celon Pharma SA
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP