Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT05187169
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2021-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Effect of VS-6766 in Healthy Adult Subjects
Sponsor:
Verastem, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: