Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT07322406

Kaempferol Absorption and Pharmacokinetics Evaluation

Led by University of Pittsburgh · Updated on 2026-03-23

120

Participants Needed

3

Research Sites

106 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

O

Otsuka Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a multi-site clinical trial designed to evaluate how the body absorbs and processes Kaempferol, a naturally occurring compound found in many plant-based foods. The primary purpose of the study is to measure the pharmacokinetics and biological absorption of Kaempferol in healthy adults. Participants will receive Kaempferol and undergo scheduled blood and urine collections over a short study period. These samples will be used to measure Kaempferol levels in the body and to assess safety and tolerability. In addition, selected biological samples will be analyzed to explore molecular changes associated with Kaempferol exposure using advanced laboratory methods. The study will be conducted at multiple research centers in the United States using a standardized protocol to ensure consistency across sites. The information collected will help improve understanding of how Kaempferol is absorbed and metabolized in humans and will support future research and regulatory evaluation.

CONDITIONS

Official Title

Kaempferol Absorption and Pharmacokinetics Evaluation

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Healthy volunteers as determined by medical history and screening assessment
  • Ability to understand the study procedures and provide informed consent
  • Willingness and ability to comply with all study procedures, including dietary restrictions, clinic visits, blood draws, urine collection, and follow-up assessments
  • Willingness to abstain from restricted foods, beverages, and supplements as specified in the study protocol during the study period
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to Kaempferol or related flavonoids
  • Pregnancy or breastfeeding
  • Presence of significant acute or chronic medical conditions that could increase risk or interfere with study outcomes, including active or chronic infections, cancer, cardiovascular disease, neurological or neurodegenerative disorders, metabolic or systemic inflammatory conditions
  • Use of prescription medications or supplements known to interfere with Kaempferol metabolism or pharmacokinetic assessment
  • Blood donation within 8 weeks prior to study enrollment
  • Participation in another interventional clinical study within a timeframe that could interfere with study results or participant safety
  • Any condition or circumstance that, in the judgment of the study investigator, would make participation unsafe or compromise data integrity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Weill Cornell Medicine

New York, New York, United States, 10065

Not Yet Recruiting

2

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Not Yet Recruiting

3

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15219

Actively Recruiting

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Research Team

A

Afshin Beheshti, PhD

CONTACT

A

Arabella Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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