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

NCT03368846 | Completed Phase 1

• 1 other identifier: ASLAN001-018
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

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

  Assessments will be made up to 13 days postdose

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

  Identification of the chemical structure of metabolites

  Assessments will be made up to 13 days postdose

Secondary Outcomes (8)

• Routes and rates of elimination of [14C] varlitinib

  Assessments will be made up to 13 days postdose

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

  Assessments will be made up to 13 days postdose

• Evaluation of whole blood:plasma concentration ratios for total radioactivity

  Assessments will be made up to 13 days postdose

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

  Assessments will be made up to 13 days postdose

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

  Assessments will be made up to 13 days postdose

Study Arms (1)

[14C]-Varlitinib

EXPERIMENTAL

Drug: Varlitinib

Interventions

Varlitinib DRUG

\[14C\]-Varlitinib

[14C]-Varlitinib

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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
• 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)
• 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)

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (1)

Quotient Clinical Ltd

Nottingham, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 11, 2017
• Study Start: November 23, 2017
• Primary Completion: December 6, 2017
• Study Completion: December 14, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)