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

Phase 1 Completed 97 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

Start: 2019-09-19
Primary completion: 2021-06-12
Completion: 2021-06-12

Publications

Kojima T, Chen W, Smulders R, Stanhope S, Kowalski D, Heo N, Moy S, Goldston A, Han D, Zhu T. First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1617, a Cathepsin-S Inhibitor, in Healthy Adult Subjects. Clin Transl Sci. 2026 Feb;19(2):e70460. doi: 10.1111/cts.70460.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP1617	Unknown	2 mg	Oral
Subject	ASP1617	Unknown	10 mg	Oral
Subject	ASP1617	Unknown	30 mg	Oral
Subject	ASP1617	Unknown	60 mg	Oral
Subject	ASP1617	Unknown	100 mg	Oral
Subject	ASP1617	Unknown	110 mg	Oral
Subject	ASP1617	Unknown	300 mg	Oral

Indications

No indication recorded.