NCT04047160

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

An Open-Label, Dose-Finding Study for the CBP / β-catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Kiminori Kimura, MD · Academic / Other
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial is a phase I trial aimed at examining the safety and tolerability of OP-724 in patients with primary biliary cholangitis and determining the recommended dose. The subjects are patients diagnosed with primary biliary cholangitis and diagnosed as progress of fibrosis (Scheuer stage III or higher) as a result of liver tissue examination. As a dosing schedule, OP-724 is intravenously administered twice a week (4 hours) for 12 weeks. However, once 7 days prior to the first cycle of administration, a dose scheduled for the first cycle will be administered once by continuous intravenous administration for 4 hours, and safety and pharmacokinetics will be evaluated on the day of administration to the next day after administration. The dose level shall be 3 doses (140 mg/m2/4hrs, 280 mg/m2/4hrs \[starting dose\], 380 mg/m2/4hrs), of which 2 doses shall be registered for up to 6 patients each. The safety and pharmacokinetic data after OP-724 administration will be decided comprehensively to determine the recommended dose in the next phase.

Conditions

• Primary Biliary Cholangitis (PBC)
• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
DRUG	OP-724	Twice a week for 4 hours continuous intravenous administration of OP-724

Timeline

• Start date: 2019-08-29
• Primary completion: 2021-09-21
• Completion: 2022-03-31
• First posted: 2019-08-06
• Last updated: 2022-07-07

Locations

2 sites across 1 country: Japan