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NCT03305471 · ClinicalTrials.gov registry record · Phase 1
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03305471 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 40 participants.
The verdict
NCT03305471, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This three-part study will be performed with participants on chronic hemodialysis. * Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b * Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day * Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.
Interventions
- DRUG Placebo
- DRUG Sevelamer
- DRUG DS-2330b PIB
- DRUG DS-2330b Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2019-01-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03305471
The ClinicalTrials.gov registry entry for NCT03305471 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03305471 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03305471 about?
NCT03305471 is a clinical study titled "DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis". This three-part study will be performed with participants on chronic hemodialysis. * Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bottle (PIB) or tablet formulations of DS2330b * Part B will test the safety, tolerability, and effects ...
What is the current status of trial NCT03305471?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-08-17. Estimated completion is 2019-01-03.
What interventions are being tested in trial NCT03305471?
The interventions under investigation include: Placebo (DRUG), Sevelamer (DRUG), DS-2330b PIB (DRUG), DS-2330b Tablet (DRUG).
Who is sponsoring clinical trial NCT03305471?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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