NCT05187169

Food Effect of VS-6766 in Healthy Adult Subjects

An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Verastem, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766

Detailed description

This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study. On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.

Conditions

• Food Effect

Interventions

Type	Name	Description
DRUG	VS-6766	Dual RAF/MEK inhibitor

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-04-12
• Completion: 2022-04-12
• First posted: 2022-01-11
• Last updated: 2022-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study