NCT04479800

Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers

A Phase 1, Three-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ASTX660	Form: capsule; Route of administration: oral

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2020-07-21
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study