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A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495934
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
Helsinn Healthcare SA

Brief Summary:
The current study is designed to generate data for the investigation of absorption, distribution, metabolism and elimination (ADME) processes of pracinostat in humans, as well as generating samples for metabolite profiling and structural identification. The mass balance recovery of pracinostat following administration of [14C]-pracinostat will be assessed, as well as metabolite profiling and identification of pracinostat in healthy male subjects. In addition, this study will provide further PK and safety data in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: pracinostat Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Pracinostat in Healthy Male Subjects
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
Experimental: single oral administration of 14C-pracinostat in the fas Drug: pracinostat
[14C]-pracinostat




Primary Outcome Measures :
  1. mass balance recovery [ Time Frame: up to 12 days ]
    urine and faeces will becollected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administrated

  2. Area Under the Curve (AUC) [ Time Frame: up to 8 days ]
    blood and plasma samples will be collected and the radioactivity measured to determine the Area under the concentration-time curve

  3. Maximum concentration (Cmax) [ Time Frame: up to 8 days ]
    blood and plasma samples will be collected and the radioactivity measured to determine the max concentration in concentration-time curve

  4. clearance (CL/F) [ Time Frame: up to 8 days ]
    systemic clearance after extravascular administration

  5. Volume of distribution (Vd/F) [ Time Frame: up to measurable concentration ]
    volume of distribution after extravascular administration

  6. terminal half life (t1/2) [ Time Frame: up to 8 days ]
    blood and plasma samples will be collected and the radioactivity measured to determine the terminal half life of the concentration-time curve



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males
  2. Age 40 to 65 years, inclusive
  3. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  4. Must be willing and able to communicate and participate in the whole study
  5. Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
  6. Subject is considered healthy on the basis of medical history, physical examination, triplicate electrocardiogram (ECG), vital signs and clinical laboratory assessments.
  7. Provision of written informed consent to participate as shown by a signature on the volunteer consent form.
  8. Male subjects must not be seeking to father a child in the next 6 months (covering 2 cycles of spermatogenesis) and must agree to use an adequate method of contraception -

Exclusion Criteria:

  1. Subjects who have received any IMP in a clinical research study within the previous 3 months
  2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  3. Subjects with pregnant partners
  4. Subjects who have previously been enrolled in this study
  5. Subjects who have been enrolled in an absorption, distribution, metabolism and elimination (ADME) study in the last 12 months
  6. History of any drug or alcohol abuse in the past 2 years
  7. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit; 1.5 to 2 units = 125 mL glass of wine, depending on type)
  8. Current smokers and those who have smoked within the last 12 months. A positive urine cotinine test at screening and admission
  9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  10. Radiation exposure, excluding background radiation but including significant medical exposures, or other trial related exposures, in the 12 months preceding participation in the trial, or radiation exposure exceeding 10 mSv in the 5 years preceding participation in the trial, inclusive of the 5 mSv exposure resulting from participation in this study. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study. Significance of a medical exposure will be determined by the investigator.
  11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  12. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
  13. Positive drugs of abuse test result
  14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  15. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
  16. Evidence of abnormal liver function at screening; alanine/aspartate aminotransferase or alkaline phosphatase > 1.5 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN
  17. White blood cells count (including differential), platelet count or red blood cell count below the lower limit of normal at screening
  18. QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 msec (using mean of triplicate ECG)
  19. History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, or psychiatric disorder, as judged by the investigator
  20. Subjects with a history of cholecystectomy or gall stones
  21. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  22. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  23. Donation or loss of greater than 400 mL of blood within the previous 3 months
  24. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
  25. Subjects who have used any medication, foods or lifestyle products that induces cytochrome P450 (CYP)-1A2, -2C8 or -3A4 in the past 28 days
  26. Any other reason why the investigator believes participation may not be in the best interests of the potential participant -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495934


Locations
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United Kingdom
Quotient Science
Ruddington, United Kingdom, NG116JS
Sponsors and Collaborators
Helsinn Healthcare SA
Quotient Sciences
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Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT03495934    
Other Study ID Numbers: PRAN-17-17
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No