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NCT03582553 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Pharmacokinetics of an Extract of Naringenin
A Early Phase 1 study, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT03582553: Completed Early Phase 1 study, sponsored by Pennington Biomedical Research Center.
NCT03582553 is a Early Phase 1 study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03582553, a Early Phase 1 study, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.
Primary Outcome
All adverse events will be recorded following the first administration of the study product or placebo. The study physician in consultation with the coordinator will review and determine whether a subject can be administered the next ascending dose. The cohorts will be run in series. There will be an interval of up to four weeks between the two cohorts. During this time an interim analysis will be conducted and a safety summary of adverse events for Cohort 1 will be compiled and reviewed by the
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Naringenin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-05-25 |
| Est. Completion | 2018-09-28 |
| Phase | Early Phase 1 |
What the finished NCT03582553 record still lists
NCT03582553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03582553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03582553 about?
NCT03582553 is a clinical study titled "Safety and Pharmacokinetics of an Extract of Naringenin". This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.
What is the current status of trial NCT03582553?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2018-05-25. Estimated completion is 2018-09-28.
What interventions are being tested in trial NCT03582553?
The interventions under investigation include: Placebo (OTHER), Naringenin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03582553?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03582553's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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