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NCT05757193 · ClinicalTrials.gov registry record · Phase 1
Ketone Pharmacokinetic Study in HFrEF
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05757193 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 20 participants.
The verdict
NCT05757193, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.
Interventions
- DIETARY_SUPPLEMENT DeltaG (250 mg/kg)
- DIETARY_SUPPLEMENT DeltaG (500 mg/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2024-01-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05757193
The ClinicalTrials.gov registry entry for NCT05757193 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DeltaG (250 mg/kg) is the first listed.
NCT05757193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05757193 about?
NCT05757193 is a clinical study titled "Ketone Pharmacokinetic Study in HFrEF". The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single vis...
What is the current status of trial NCT05757193?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-06-02. Estimated completion is 2024-01-11.
What interventions are being tested in trial NCT05757193?
The interventions under investigation include: DeltaG (250 mg/kg) (DIETARY_SUPPLEMENT), DeltaG (500 mg/kg) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05757193?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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