Early Phase 1
Completed N=18
Safety and Pharmacokinetics of an Extract of Naringenin
Safety Issues · Pharmacokinetics
Source: ClinicalTrials.gov NCT03582553 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin — 1; 2; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin |
1; 2; 0; 1; 1; 1 | — |
| SECONDARY Measurement of Area Under the Serum Naringenin Concentration Versus Time Curve at 150 and 600 mg Doses |
18.41; 54.19; 0.08 | — |
| SECONDARY Measurement of Maximal Concentration of Serum Naringenin at 150 and 600 mg Doses |
4.29; 13.19; 0.009 | — |
| SECONDARY Measurement of Time to Peak Concentration of Serum Naringenin at 150 and 600 mg Doses |
3.17; 2.41; 0 | — |
| SECONDARY Measurement of Half Life of Naringenin at 150 and 600 mg Doses |
3.0; 2.65; 0 | — |
| SECONDARY Measurement of Apparent Oral Clearance of Naringenin at 150 and 600 mg Doses |
10.21; 13.7; 0 | — |
| SECONDARY Measurement of Four-hour Concentration of Serum Naringenin at 300 and 900 mg Doses |
10.7; 43.1; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03582553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.