Clinical trial NCT02232269: Coffee Interaction With the Antihypertensive Drug Felodipine
Official title: Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food-Drug Interactions
Keywords: Coffee
Grapefruit Juice
Felodipine
Calcium Channel Blocker
Hemodynamics
CYP3A4
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world.

Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago.

We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.


Eligibility criteria: Inclusion Criteria:

* healthy (normal physical exam, blood clinical chemistry)
* willingly signs ethics approved informed consent form

Exclusion Criteria:

* history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse
* significant illness within 2 weeks of starting study
* history of allergy to felodipine , tablet ingredients or dihydropyridines
* routinely taking prescription or OTC drugs or natural health products
* received an investigational drug withing the previous 4 weeks
* females who are pregnant or breast-feeding

Primary outcomes:
measure: The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
timeFrame: Change from Baseline to 8 hours Post Dose
Secondary outcomes:
measure: The effect of coffee on the oral pharmacokinetics of felodipine.
timeFrame: Change from Baseline to 8 hours Post Dose
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Clinical Trials Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: David G Bailey, BScPhm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081.
citation: Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346.