NCT04077879

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect

A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including an Assessment of a Food Effect

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.

Detailed description

After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP1617	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-06-12
• Completion: 2021-06-12
• First posted: 2019-09-04
• Last updated: 2024-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study