Kaempferol for Healthy Subjects
(KAPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Afshin Beheshti, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Healthy adults aged 18 to 70 who understand the study and agree to its procedures, including dietary restrictions, clinic visits, blood draws, urine collection, and follow-ups. Participants must avoid certain foods, drinks, and supplements as outlined in the protocol.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral Kaempferol administered as capsules once daily for 8 days with scheduled blood and urine collections
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and laboratory evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Kaempferol
Trial Overview
The trial is studying how Kaempferol—a compound found in plants—is absorbed and processed by healthy adults. It involves taking Kaempferol followed by regular blood and urine tests to measure its levels in the body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this single-arm intervention receive oral Kaempferol (KMP) administered as capsules once daily for 8 days as part of a controlled dietary regimen. All participants undergo standardized pharmacokinetic blood and urine sampling at predefined time points, along with safety monitoring and comprehensive multi-omics analyses to assess absorption, metabolism, tolerability, and biological responses to Kaempferol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Industry Sponsor
Tarek Rabah
Otsuka Pharmaceutical Co., Ltd.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University
John Kraus
Otsuka Pharmaceutical Co., Ltd.
Chief Medical Officer since 2021
MD and PhD in Neurobiology from Duke University
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