Clinical Study

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

Posted Date: Jan 13, 2025

  • Investigator: Khurram Bari
  • Specialties:
  • Type of Study: Drug

This is a Phase 1 open-label, single- and multiple-dose study to evaluate the pharmacokinetics (PK) and safety of K-808 in subjects with PBC w/o CIRR (Group 1) and subjects with PBC w/ CIRR CP-A (Group 2) after a single dose and multiple-dose administration of K-808. Following signed informed consent, subjects will be screened for eligibility during a 6-week Screening Period prior to enrollment in the study. Approximately 16 subjects (approximately eight subjects per group, with a minimum of six subjects per group) will be enrolled and assigned based on their PBC status to one of two groups: • Group 1: subjects with PBC w/o CIRR (K-808 0.4 mg) • Group 2: subjects with PBC w/ CIRR CP-A (K-808 0.2 mg)

Criteria:

Patient With Primary Biliary Cholangitis With Compensated Cirrhosis Or Without Cirrhosis. Subjects With Any Additional Chronic Liver Conditions, Use Of Fenofibrate Or Ocaliva Or Those Having Clinically Significant Portal Hypertension Are Excluded.

Keywords:

Pemafibrate, Primary Biliary Cholangitis, Cirrhosis

For More Information:

Tonya Dorst
513-558-0046
dorsttm@ucmail.uc.edu