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

NCT03495934 | Completed Phase 1 FDA Drug

• 1 other identifier: PRAN-17-17
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• mass balance recovery

  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

  up to 12 days

• Area Under the Curve (AUC)

  blood and plasma samples will be collected and the radioactivity measured to determine the Area under the concentration-time curve

  up to 8 days

• Maximum concentration (Cmax)

  blood and plasma samples will be collected and the radioactivity measured to determine the max concentration in concentration-time curve

  up to 8 days

• clearance (CL/F)

  systemic clearance after extravascular administration

  up to 8 days

• Volume of distribution (Vd/F)

  volume of distribution after extravascular administration

  up to measurable concentration

• terminal half life (t1/2)

  blood and plasma samples will be collected and the radioactivity measured to determine the terminal half life of the concentration-time curve

  up to 8 days

Study Arms (1)

single oral administration of 14C-pracinostat in the fas

EXPERIMENTAL

Drug: pracinostat

Interventions

pracinostat DRUG

\[14C\]-pracinostat

single oral administration of 14C-pracinostat in the fas

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males
• Age 40 to 65 years, inclusive
• Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
• Must be willing and able to communicate and participate in the whole study
• Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
• Subject is considered healthy on the basis of medical history, physical examination, triplicate electrocardiogram (ECG), vital signs and clinical laboratory assessments.
• Provision of written informed consent to participate as shown by a signature on the volunteer consent form.
• 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 -

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects with pregnant partners
• Subjects who have previously been enrolled in this study
• Subjects who have been enrolled in an absorption, distribution, metabolism and elimination (ADME) study in the last 12 months
• History of any drug or alcohol abuse in the past 2 years
• 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)
• Current smokers and those who have smoked within the last 12 months. A positive urine cotinine test at screening and admission
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• 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.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \<80 mL/min using the Cockcroft-Gault equation

Sponsors & Collaborators

• Helsinn Healthcare SA: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Science

Ruddington, NG116JS, United Kingdom

Location

MeSH Terms

Interventions

SB939 compound

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 12, 2018
• Study Start: February 8, 2018
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

GB (1)