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Healthy SubjectsPhase 1NCT03495934

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

A Phase 1 study testing pracinostat in people with Healthy Subjects, run by Helsinn Healthcare SA at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
pracinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
8 Feb 2018to 28 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 -

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • 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
  • White blood cells count (including differential), platelet count or red blood cell count below the lower limit of normal at screening
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 msec (using mean of triplicate ECG)
  • History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, or psychiatric disorder, as judged by the investigator
  • Subjects with a history of cholecystectomy or gall stones
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • 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.
  • Subjects who have used any medication, foods or lifestyle products that induces cytochrome P450 (CYP)-1A2, -2C8 or -3A4 in the past 28 days
  • Any other reason why the investigator believes participation may not be in the best interests of the potential participant -

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Science

    Ruddington, NG116JS

Other trials in United Kingdom

About this study

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

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.

Being tested
pracinostat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pracinostatDrug

    [14C]-pracinostat

Study groups in NCT03495934
Study groupRoleWhat they receive
single oral administration of 14C-pracinostat in the fasExperimentalNot described
Receives: Drug: pracinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 12 days

  2. 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

    Measured: up to 8 days

  3. Maximum concentration (Cmax)

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

    Measured: up to 8 days

  4. clearance (CL/F)

    systemic clearance after extravascular administration

    Measured: up to 8 days

  5. Volume of distribution (Vd/F)

    volume of distribution after extravascular administration

    Measured: up to measurable concentration

  6. 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

    Measured: up to 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start8 Feb 2018
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495934
Sponsor's protocol ID
PRAN-17-17
Status last verified
Aug 2019
First submitted
28 Mar 2018
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pracinostat in people with Healthy Subjects, run by Helsinn Healthcare SA at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mass balance recovery (time frame: up to 12 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.

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