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NCT06619054 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001
A Phase 1 study, sponsored by Kaken Pharmaceutical.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT06619054 is a Phase 1 study that has completed, run by Kaken Pharmaceutical. The registered enrollment target is 24 participants.
The verdict
NCT06619054, a Phase 1 study, has completed, sponsored by Kaken Pharmaceutical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase 1, open-label, non-randomized, parallel-group, single-dose study to assess the effect of hepatic impairment (assessed by the criteria of the Child-Pugh scale) on the pharmacokinetics (PK) and safety of KP-001 in adult male and non-childbearing potential female participants aged ≥20 years old. The purpose of this study is to evaluate the effect of hepatic impairment on the PK and safety of KP-001. The study will also assess the effect of hepatic impairment on other PK parameters after single dose administration of KP-001. The study will comprise 3 parts, and the study period for each part will consist of the following: * Screening period: Up to 28 days before the administration of study intervention * Treatment Period: Participants will be residential at the Clinical Unit from the day before the administration of the single dose of KP-001 (Day -1) until Day 3 (Discharge) * Follow-up Visit: 7 days after discharge from the Clinical Unit (ie, Day 10) Participants will be enrolled into 4 cohorts according to the hepatic function status as summarized below. The study includes a control group of healthy participants with normal hepatic function.
Interventions
- DRUG KP-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06619054
The ClinicalTrials.gov registry entry for NCT06619054 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaken Pharmaceutical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which KP-001 is the first listed.
NCT06619054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06619054 about?
NCT06619054 is a clinical study titled "A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001". This is a phase 1, open-label, non-randomized, parallel-group, single-dose study to assess the effect of hepatic impairment (assessed by the criteria of the Child-Pugh scale) on the pharmacokinetics (PK) and safety of KP-001 in adult male and non-childbearing potential female participants aged ≥20 y...
What is the current status of trial NCT06619054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-10-24. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT06619054?
The interventions under investigation include: KP-001 (DRUG).
Who is sponsoring clinical trial NCT06619054?
This trial is sponsored by Kaken Pharmaceutical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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