Food-Drug InteractionsPhase 1NCT02232269
Coffee Interaction With the Antihypertensive Drug Felodipine
A Phase 1 study testing Black Coffee, Grapefruit Juice and Water in people with Food-Drug Interactions, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food-Drug Interactions
- What is being tested?
- Black Coffee, Grapefruit Juice and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy (normal physical exam, blood clinical chemistry)
- willingly signs ethics approved informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
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.
- Conditions
- Food-Drug Interactions
- Being tested
- Black Coffee, Grapefruit Juice, Water, Felodipine
- Keywords
- Coffee, Grapefruit Juice, Felodipine, Calcium Channel Blocker, Hemodynamics, CYP3A4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black CoffeeOther
Grapefruit JuiceOther
WaterOther
FelodipineDrug
Also called Plendil, Renadil
| Study group | Role | What they receive |
|---|---|---|
| Water plus Felodipine | Placebo comparator | Felodipine extended-release tablet ,10 mg, single dose, 8 hours Receives: Other: Water; Drug: Felodipine |
| Black Coffee | Active comparator | Black Coffee, 300 ml, 0 and 1 hour Receives: Other: Black Coffee |
| Black Coffee plus Felodipine | Experimental | Black Coffee, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours Receives: Other: Black Coffee; Drug: Felodipine |
| Grapefruit Juice plus Felodipine | Active comparator | Grapefruit Juice, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours Receives: Other: Grapefruit Juice; Drug: Felodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA).
Measured: Change from Baseline to 8 hours Post Dose
Secondary outcomes (1)
The effect of coffee on the oral pharmacokinetics of felodipine.
Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose
Measured: Change from Baseline to 8 hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food-Drug InteractionsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bailey, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David G Bailey, BScPhm, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232269
- Sponsor's protocol ID
- R-11-655
- Other IDs
- NA-7122
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27481881Dresser 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.
PubMed 28971609
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
- ClinicalTrials.gov ID
- NCT02232269
- Acronym / sponsor ID
- R-11-655
- Conditions
- Food-Drug Interactions
- Keywords
- Coffee, Grapefruit Juice, Felodipine, Calcium Channel Blocker, Hemodynamics, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water plus Felodipine | Placebo comparator | Other: Water, Drug: FelodipineFelodipine extended-release tablet ,10 mg, single dose, 8 hours |
| Black Coffee | Active comparator | Other: Black CoffeeBlack Coffee, 300 ml, 0 and 1 hour |
| Black Coffee plus Felodipine | Experimental | Other: Black Coffee, Drug: FelodipineBlack Coffee, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours |
| Grapefruit Juice plus Felodipine | Active comparator | Other: Grapefruit Juice, Drug: FelodipineGrapefruit Juice, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy (normal physical exam, blood clinical chemistry)
- willingly signs ethics approved informed consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black Coffee | Other | Black Coffee, Black Coffee plus Felodipine |
| Grapefruit Juice | Other | Grapefruit Juice plus Felodipine |
| Water | Other | Water plus Felodipine |
| FelodipineAlso: Plendil, Renadil | Drug | Black Coffee plus Felodipine, Grapefruit Juice plus Felodipine, Water plus Felodipine |
Primary outcome
The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
Time frame: Change from Baseline to 8 hours Post Dose
Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA).
1 secondary outcome
The effect of coffee on the oral pharmacokinetics of felodipine.
Time frame: Change from Baseline to 8 hours Post Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Background: PubMed 27481881Bailey 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.
- Background: PubMed 28971609Dresser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Bailey, BScPhm, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Black Coffee, Grapefruit Juice and Water in people with Food-Drug Interactions, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . (time frame: Change from Baseline to 8 hours Post Dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.