NCT05278845

Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects

A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: SignalChem Lifesciences Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, Phase 1, open-label, randomized, single dose, 2-period, 2-sequence, crossover study to evaluate the PK, safety, and tolerability of a single oral dose of SLC-391 under fed and fasted conditions in approximately 22 healthy male and non-childbearing potential female subjects. Subjects will be randomized in a 1:1 ratio to one of two treatment sequences with 11 subjects per treatment sequence. Each subject will receive both treatments (Treatment A and Treatment B) with a washout period of at least 7 days between successive SLC-391.

Conditions

• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	SLC-391	SLC-391 is an AXL inhibitor

Timeline

• Start date: 2022-02-12
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2022-03-14
• Last updated: 2022-08-01

Locations

1 site across 1 country: Canada