NCT03368846

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

Completed Phase 1 Last updated 11 September 2018

What this trial tests

Phase 1 trial testing Varlitinib in Healthy Volunteers in 6 participants. Completed in 14 December 2017.

Timeline

23 November 2017

Primary endpoint
6 December 2017

14 December 2017

Quick facts

Lead sponsor	ASLAN Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	23 November 2017
Primary completion	6 December 2017
Estimated completion	14 December 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Varlitinib — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

ASLAN Pharmaceuticals — full company profile →

Who can join

Adults 30 to 65, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Small Molecules against Metastatic Tumors: Concrete Perspectives and Shattered Dreams.
   Serra M, Rubes D, Schinelli S, Paolillo M. · · 2023 · cited 12× · PMID 37627201 · DOI 10.3390/cancers15164173