Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:14 PM
Study NCT ID:
NCT04479800
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers
Sponsor:
Astex Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Three-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions.
Detailed Description:
Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA) standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10 hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before dosing. The duration of the study is expected to be approximately 47 days.
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?: