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NCT04190654 · ClinicalTrials.gov registry record · Phase 1
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
A Phase 1 study, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04190654: Completed Phase 1 study, sponsored by Kyowa Kirin.
NCT04190654 is a Phase 1 study that has completed, run by Kyowa Kirin. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04190654, a Phase 1 study, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy adults
Primary Outcome
Maximum observed concentration (KW-6356 and its major metabolite in plasma).
Interventions
- DRUG KW-6356
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 1 |
What the finished NCT04190654 record still lists
NCT04190654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which KW-6356 is the first listed.
NCT04190654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04190654 about?
NCT04190654 is a clinical study titled "Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite". This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy adults
What is the current status of trial NCT04190654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-11-26. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT04190654?
The interventions under investigation include: KW-6356 (DRUG).
Who is sponsoring clinical trial NCT04190654?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04190654's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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