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NCT03223337 · ClinicalTrials.gov registry record · Phase 1
Daprodustat Hepatic Impairment Study
A Phase 1 study of Anaemia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT03223337 is a Phase 1 study of Anaemia that has completed, run by GlaxoSmithKline. The registered enrollment target is 37 participants, below the 63-participant average among 3 other Anaemia trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03223337, a Phase 1 study of Anaemia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of anemia of chronic kidney disease (CKD). Results of the earlier studies shows that liver is involved in the clearance of Daprodustat and hence, hepatic impairment can affect Daprodustat levels in the body. This single dose study will assess the effect of liver impairment on the pharmacokinetics (PK) and pharmacodynamics (PD) of daprodustat. The study will be conducted in two parts, Part 1 will include subjects with moderate hepatic impairment and matched healthy control subjects whereas Part 2 will include subjects will either mild or severe hepatic impairment and matched healthy control subjects. Approximately 8 subjects will be included in each of the group and all subjects will receive 6 milligram (mg) of daprodustat as a single oral dose in the fasted state. Total duration of participation in the study for a subject will be up to 7 weeks.
Conditions Studied
Interventions
- DRUG Daprodustat (GSK1278863)
Study Locations (2)
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-07-24 |
| Est. Completion | 2018-08-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03223337
The ClinicalTrials.gov registry entry for NCT03223337 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 63-participant average among 3 other Anaemia trials with a reported enrollment target (41% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anaemia appearing as the primary indexed condition, and to 1 intervention - of which Daprodustat (GSK1278863) is the first listed.
NCT03223337 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03223337 about?
NCT03223337 is a clinical study titled "Daprodustat Hepatic Impairment Study". Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of anemia of chronic kidney disease (CKD). Results of the earlier studies shows that liver is involved in the clearance of Daprodustat and hence, hepatic impairment can affect Daprodustat levels in the body. Thi...
What is the current status of trial NCT03223337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2017-07-24. Estimated completion is 2018-08-20.
What conditions does trial NCT03223337 study?
This clinical trial studies the following conditions: Anaemia.
What interventions are being tested in trial NCT03223337?
The interventions under investigation include: Daprodustat (GSK1278863) (DRUG).
Who is sponsoring clinical trial NCT03223337?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03223337 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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