deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm 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

Sponsor: Kowa Research Institute, Inc.

Interventions K-808
Updated 8 times since 2024 Last updated: May 22, 2025 Started: Oct 1, 2024 Primary completion: Mar 12, 2025 Completion: Apr 9, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06525311, this PHASE1 trial focuses on Compensated Cirrhosis and Primary Biliary Cholangitis and remains completed. Sponsored by Kowa Research Institute, Inc., it has been updated 8 times since 2024, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Mar 2025 · 3 months · monthly snapshotRecruiting~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – present · 15 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jun 2025 — Present [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

  2. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1

  3. Mar 2025 — May 2025 [monthly]

    Recruiting PHASE1

  4. Dec 2024 — Mar 2025 [monthly]

    Recruiting PHASE1

  5. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

Show 3 earlier versions
  1. Oct 2024 — Nov 2024 [monthly]

    Not Yet Recruiting PHASE1

  2. Sep 2024 — Oct 2024 [monthly]

    Not Yet Recruiting PHASE1

  3. Aug 2024 — Sep 2024 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kowa Research Institute, Inc.
Data source: Kowa Research Institute, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .