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NCT06525311 · ClinicalTrials.gov registry record · Phase 1

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 study, sponsored by Kowa Research Institute.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT06525311: Completed Phase 1 study, sponsored by Kowa Research Institute.

NCT06525311 is a Phase 1 study that has completed, run by Kowa Research Institute. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06525311, a Phase 1 study, has completed, sponsored by Kowa Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study 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.

Interventions

  • DRUG K-808

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2024-10-01
Est. Completion 2025-04-09
Phase Phase 1
Kowa Research Institute

44 total trials

What the finished NCT06525311 record still lists

NCT06525311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which K-808 is the first listed.

NCT06525311 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06525311 about?

NCT06525311 is a clinical study titled "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 Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

What is the current status of trial NCT06525311?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2024-10-01. Estimated completion is 2025-04-09.

What interventions are being tested in trial NCT06525311?

The interventions under investigation include: K-808 (DRUG).

Who is sponsoring clinical trial NCT06525311?

This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06525311's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06525311, the US trial registry maintained by the National Library of Medicine. NCT06525311 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.