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NCT04534699 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
A Phase 1 study, sponsored by KBP Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04534699: Completed Phase 1 study, sponsored by KBP Biosciences.
NCT04534699 is a Phase 1 study that has completed, run by KBP Biosciences. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534699, a Phase 1 study, has completed, sponsored by KBP Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
Primary Outcome
Maximum observed concentration (Cmax) - Plasma
Interventions
- DRUG KBP-5074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-08-27 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 1 |
What the finished NCT04534699 record still lists
NCT04534699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which KBP-5074 is the first listed.
NCT04534699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534699 about?
NCT04534699 is a clinical study titled "Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment". This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
What is the current status of trial NCT04534699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-08-27. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT04534699?
The interventions under investigation include: KBP-5074 (DRUG).
Who is sponsoring clinical trial NCT04534699?
This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534699's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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