Safety and Pharmacokinetics of an Extract of Naringenin
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Safety Issues, Pharmacokinetics
In brief
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.
Key facts
- Study ID
- NCT03582553
- Run by
- Pennington Biomedical Research Center
- People needed
- 18
- Starts
- 2018-05-25
- Expected to finish
- 2018-09-28
- Last updated by the study team
- 2020-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult (≥18 years)
- Body mass index between 20 and 35 kg/m2
- Must have fasting blood sugar <126 mg/dL)
- Must be willing to refrain from consuming citrus fruits and tomato in any form, for 36 hours prior to each test day.
You may not qualify if…
- Report citrus allergies.
- Report a history of cardiovascular disease, diabetes, or cancer
- Have evidence of hepatic disease or dysfunction
- Are currently pregnant or breastfeeding
- Are women of childbearing potential who will not use an effective method of birth control
- Chronically use of medications except over the counter medications that have been stopped 72 hours prior to the study visit
- Report clinically significant GI malabsorption syndromes
- Have clinically significant abnormal laboratory markers
- Anticipate surgery during the study period.
- Report history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
- Have donated blood during the month prior to study entry or plan to do so during the study.
- Have participated in other studies using an investigational drug during the preceding three months.
- Are current smokers or have smoked within the previous three months.
Where it is running
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
Full record on ClinicalTrials.gov
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