Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05157672
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2021-12-01
Brief Title:
Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon
Sponsor:
Washington State University
Organization:
Washington State University
Study Overview
Official Title:
Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a well-characterized commercially available cinnamon dietary supplement as a precipitant of pharmacokinetic interactions with cytochrome P450 CYP 2A6 drug substrates in healthy volunteers Nicotine gum will be used as the CYP2A6 probe drug ie positive control and letrozole as a high-impact object drug Results will be used to inform future research on the potential use of cinnamon as a smoking cessation agent as well as the clinical impact on pharmacotherapeutic regimens involving letrozole in cancer patients
Detailed Description:
Cinnamon is used worldwide as both an additive and a botanical dietary supplement the latter of which ranked within the 30 top-selling herbal supplements in 2020 Cinnamon is added to a variety of products ranging from foods eg breakfast cereals baked goods to fragrances and essential oils to improve taste or smell As a dietary supplement cinnamon is commonly used to lower blood sugar and reduce inflammation Cinnamon contains the abundant component cinnamaldehyde CA a phenylpropanoid that emanates the flavor and scent of cinnamon Research by Harrelson and colleagues has shown CA to inhibit the drug metabolizing enzyme cytochrome P450 CYP 2A6 in a time-dependent manner That is CYP2A6 metabolizes CA to a reactive intermediate that destroys the enzyme Such substrates are also referred to as suicide substrates This type of enzyme inhibition is similar to that of grapefruit juice which contains furanocoumarins that are time-dependent inhibitors of CYP3A in the intestine leading to numerous potential adverse interactions with drugs metabolized by CYP3A Unlike competitive inhibitors time-dependent inhibitors inactivate the enzyme permanently requiring de novo synthesis of the enzyme As such drug interactions with time-dependent inhibitors can last for several days Relative to CYP3A the list of clinically relevant CYP2A6 substrates is very short However two critical substrates include nicotine and the anticancer agent letrozole Using an in vitro-to-in vivo extrapolation approach CA was predicted to increase the area under the plasma concentration vs time curve AUC of both substrates by 4- to 5-fold exceeding the FDA recommended cutoff 125 These compelling observations prompted this clinical study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54AT008909 | NIH | None | httpsreporternihgovquickSearchU54AT008909 |