NCT04303039

Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects

A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.

Conditions

• Gout
• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	ABP-671	ABP-671 Tablet 1.0 mg

Timeline

• Start date: 2020-05-22
• Primary completion: 2020-06-09
• Completion: 2020-06-19
• First posted: 2020-03-10
• Last updated: 2020-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study