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NCT04276662 · ClinicalTrials.gov registry record · Phase 1
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT04276662: Completed Phase 1 study of Hepatic Impairment, sponsored by Daiichi Sankyo.
NCT04276662 is a Phase 1 study of Hepatic Impairment that has completed, run by Daiichi Sankyo. The registered enrollment target is 28 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (22% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04276662, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
Primary Outcome
Cmax is the maximum concentration of DS-3201a in plasma
Conditions Studied
Interventions
- DRUG DS-3201b
Study Locations (3)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
- Orlando Clinical Research Center - Orlando
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2021-02-23 |
| Phase | Phase 1 |
What the finished NCT04276662 record still lists
NCT04276662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which DS-3201b is the first listed.
NCT04276662 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04276662 about?
NCT04276662 is a clinical study titled "Study of Single-dose DS-3201b in Participants With Hepatic Impairment". This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
What is the current status of trial NCT04276662?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-11-21. Estimated completion is 2021-02-23.
What conditions does trial NCT04276662 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT04276662?
The interventions under investigation include: DS-3201b (DRUG).
Who is sponsoring clinical trial NCT04276662?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04276662 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04276662's enrollment target sits among peer trials
28 27th of 48 higher than 20 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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