AzTrials
AzTrials

Healthy VolunteersPhase 1NCT03368846

Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib

A Phase 1 study testing Varlitinib in people with Healthy Volunteers, run by ASLAN Pharmaceuticals 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
Search all trials

Trial summary

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in 4 evaluable subjects. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Varlitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
23 Nov 2017to 14 Dec 2017
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 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males of non-Asian descent
  • Aged 30 to 65 years
  • 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 provide written informed consent
  • Must agree to use an adequate method of contraception (as defined in Section 9.4)
  • Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
  • Subject is considered healthy on the basis of medical history, physical examination, ECG, vital signs and clinical laboratory assessments.

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
  • 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 or a 125 mL glass of wine)
Show all 25Show fewer
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission
  • Users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
  • Neutrophil count <1.8 x109/L at screening
  • ALT and AST >1.25 x upper limit of normal range at screening
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 msec at screening
  • Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
  • 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 (CLcr) of <80 mL/min using the Cockcroft-Gault equation
  • History of clinically relevant cardiovascular, renal, hepatic, chronic respiratory or Gl disease, neurological or psychiatric disorder, as judged by the investigator
  • History of clinically relevant dermatological disease (eg eczema, psoriasis, drug rashes) or the presence of dermatological conditions at screening (eg acne, eczema, dermatitis etc)
  • 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 or herbal remedies in the 14 days before IMP administration; with the exception of 4 g per day paracetamol [see Section 11.4]). Further 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.
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Clinical Ltd

    Nottingham

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]-Varlitinib in Healthy Male Subjects

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in 4 evaluable subjects.

Each subject will receive a single administration of 120 mg [14C] varlitinib oral suspension containing not more than (NMT) 2.9 MBq (79 µCi), in the fed state.

Read the detailed description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day 1) and will fast overnight for a minimum of 8 h. Subjects will be dosed on the morning of Day 1 following a light breakfast, and will remain resident in the clinic until up to 240 h after dosing (Day 11). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90%, or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces) will cease and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects on Day 11, the residency period may be extended by a further 48 h maximum (up to Day 13). If the criterion is still not met by Day 13, or if additional residency is not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects.

Being tested
Varlitinib

What participants receive

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

  • VarlitinibDrug

    [14C]-Varlitinib

Study groups in NCT03368846
Study groupRoleWhat they receive
[14C]-VarlitinibExperimentalNot described
Receives: Drug: Varlitinib

What is being measured

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

  1. Mass balance recovery after a single oral dose of [14C] varlitinib

    Mass balance recovery of [14C] varlitinib recovered in urine, faeces, and all excreta

    Measured: Assessments will be made up to 13 days postdose

  2. Metabolite profiling and structural identification of metabolites in plasma, urine and faeces

    Identification of the chemical structure of metabolites

    Measured: Assessments will be made up to 13 days postdose

Secondary outcomes (8)

  1. Routes and rates of elimination of [14C] varlitinib

    Amount [14C] varlitinib excreted for urine and faeces

    Measured: Assessments will be made up to 13 days postdose

  2. Determination of the chemical structure of the "major" metabolites of [14C] varlitinib

    Identification of the chemical structure of each metabolite accounting for greater than 10%

    Measured: Assessments will be made up to 13 days postdose

  3. Evaluation of whole blood:plasma concentration ratios for total radioactivity

    Measured: Assessments will be made up to 13 days postdose

  4. PK of total radioactivity and varlitinib in plasma following a single oral dose of [14C] varlitinib

    Peak Plasma Concentration (Cmax)

    Measured: Assessments will be made up to 13 days postdose

  5. PK of total radioactivity and varlitinib in plasma following a single oral dose of [14C] varlitinib

    Area under the plasma concentration versus time curve (AUC)

    Measured: Assessments will be made up to 13 days postdose

  6. PK of total radioactivity and varlitinib in plasma following a single oral dose of [14C] varlitinib

    Half life

    Measured: Assessments will be made up to 13 days postdose

  7. PK of total radioactivity and varlitinib in plasma following a single oral dose of [14C] varlitinib

    The time from dosing at which Cmax was apparent

    Measured: Assessments will be made up to 13 days postdose

  8. Collect additional information on the safety and tolerability of varlitinib

    Number of participants with abnormal laboratory values and/or adverse events

    Measured: Assessments will be made up to 13 days postdose

Timeline

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

  1. First posted11 Dec 2017
  2. Study start23 Nov 2017
  3. Primary completion6 Dec 2017
  4. Study completion14 Dec 2017

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03368846
Sponsor's protocol ID
ASLAN001-018
Status last verified
Sep 2018
First submitted
22 Nov 2017
Last updated
11 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Varlitinib in people with Healthy Volunteers, run by ASLAN Pharmaceuticals 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 25 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 11 Sep 2018. 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 after a single oral dose of [14C] varlitinib (time frame: Assessments will be made up to 13 days postdose). The study lists 2 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 NCT03368846.

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 11 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in