drugset

drugset / Trial / NCT04047160

Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)

NCT04047160 ↗

Phase 1 Completed 7 enrolled Kiminori Kimura, MD Japan Agency for Medical Research and Development · collab Ohara Pharmaceutical Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.

Timeline

Start: 2019-08-29
Primary completion: 2021-09-21
Completion: 2022-03-31

Publications

Kimura M, Ogawa E, Harada K, Imamura J, Saio M, Ikura Y, Yatsuhashi H, Murata K, Miura K, Ieiri I, Tanaka A, Kimura K. Feasibility, safety and tolerability of the CREB-binding protein/beta-catenin inhibitor OP-724 in patients with advanced primary biliary cholangitis: an investigator-initiated, open-label, non-randomised, two-centre, phase 1 study. BMJ Open Gastroenterol. 2022 Nov;9(1):e001001. doi: 10.1136/bmjgast-2022-001001.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OP-724	Unknown	140 mg/m2	Intravenous
Subject	OP-724	Unknown	280 mg/m2	Intravenous
Subject	OP-724	Unknown	380 mg/m2	Intravenous

Indications