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

NCT03368846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-11

No results posted yet for this study

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

Interventions

DRUG

Varlitinib

\[14C\]-Varlitinib

Sponsors & Collaborators

  • ASLAN Pharmaceuticals

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2017-12-06
Completion
2017-12-14

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368846 on ClinicalTrials.gov