Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

Summary

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Timeline

Start

2014-06

Primary completion

2016-08

Completion

2016-08

Publications

• Bae SH, Kang J, Jeon S, Kim SM, Kim HT, Han S, Han S. Pharmacokinetic-Pharmacodynamic Modeling and Simulation of Merigolix, a Nonpeptide Gonadotropin-Releasing Hormone Antagonist. Clin Pharmacokinet. 2026 Mar;65(3):377-393. doi: 10.1007/s40262-025-01595-0. Epub 2025 Dec 20.
• Han S, Cho YS, Yoon SK, Lim KS, Cho SH, Kim J, Choe S, Jung J, Ghim JL, Choi S, Lee M, Kim SM, Kim HT, Lim HS, Yoon Shim J, Bae KS. First-in-Human, Double-Blind, Randomized Controlled Trial of an Oral Dose of GnRH Antagonist TU2670 in Healthy Women. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1111-e1120. doi: 10.1210/clinem/dgaa939.

Drugs

Indications