NCT06525311

A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.

A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

Conditions

• Primary Biliary Cholangitis
• Compensated Cirrhosis

Interventions

Type	Name	Description
DRUG	K-808	K-808 single or multi dose extended-release tablets

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-12
• Completion: 2025-04-09
• First posted: 2024-07-29
• Last updated: 2025-05-23

Locations

10 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study