drugset / Trial / NCT05157672

Evaluating the Pharmacokinetics and Drug Interaction Potential of the Botanical Dietary Supplement Cinnamon

Phase 0 Unknown 16 enrolled Washington State University National Center for Complementary and Integrative Health (NCCIH) · collab Office of Dietary Supplements (ODS) · collab

Non-randomizedCrossoverOpen-labelBasic science

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 (i.e., 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.

Timeline

Start: 2021-12-14
Primary completion: 2023-08-31
Completion: 2024-08-31

Publications

Background Smith T, Majid F, Eckl V, and Reynolds CM (2021) Herbal Supplement Sales in US Increase by Record-Breaking 17.3% in 2020. HerbalGram 131:52-65.
Background Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007170. doi: 10.1002/14651858.CD007170.pub2.
Background Chan J, Oshiro T, Thomas S, Higa A, Black S, Todorovic A, Elbarbry F, Harrelson JP. Inactivation of CYP2A6 by the Dietary Phenylpropanoid trans-Cinnamic Aldehyde (Cinnamaldehyde) and Estimation of Interactions with Nicotine and Letrozole. Drug Metab Dispos. 2016 Apr;44(4):534-43. doi: 10.1124/dmd.115.067942. Epub 2016 Feb 5.
Background Espiritu MJ, Chen J, Yadav J, Larkin M, Pelletier RD, Chan JM, Gc JB, Natesan S, Harrelson JP. Mechanisms of Herb-Drug Interactions Involving Cinnamon and CYP2A6: Focus on Time-Dependent Inhibition by Cinnamaldehyde and 2-Methoxycinnamaldehyde. Drug Metab Dispos. 2020 Oct;48(10):1028-1043. doi: 10.1124/dmd.120.000087. Epub 2020 Aug 12.
Background FDA (2020) Drug Interactions: Relevant Regulatory Guidance and Policy Documents
Background Paine MF, Shen DD, McCune JS. Recommended Approaches for Pharmacokinetic Natural Product-Drug Interaction Research: a NaPDI Center Commentary. Drug Metab Dispos. 2018 Jul;46(7):1041-1045. doi: 10.1124/dmd.117.079962. Epub 2018 May 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Nicotine	Unknown	2.5 mg	—

Indications

No indication recorded.