PharmacokineticsNCT01034124
Mechanisms Underlying Drug-Diet Interactions
A study testing warfarin, vitamin K, midazolam in people with Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- warfarin, vitamin K, midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2008
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Healthy
- Not taking medications known to modulate CYP2C9 and CYP3A activity
- Able to understand the consent process
Who cannot join
- Allergy to cranberry products, warfarin, vitamin K, or midazolam
- Pregnant or breast-feeding women
- Baseline INR >1.2
- History of significant medical conditions that could increase risk
- Concomitant medications known to modulate CYP2C9 and CYP3A activity
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-Chapel Hill General Clinical Research Center
Chapel Hill, North Carolina, 27599
About this study
Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.
- Conditions
- Pharmacokinetics
- Being tested
- warfarin, vitamin K, midazolam
- Keywords
- warfarin, midazolam, cranberry juice, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarin, vitamin K, midazolamDrug
Also called Coumadin, Mephyton, Versed
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Not described Receives: Drug: warfarin, vitamin K, midazolam |
| Cranberry juice | Active comparator | Not described Receives: Drug: warfarin, vitamin K, midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: 0-96 hr
Secondary outcomes (1)
Cmax
Measured: varies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Mary F Paine, Ph.D., Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034124
- Sponsor's protocol ID
- UNC-CH 05-2951
- Status last verified
- Dec 2009
- First submitted
- 15 Dec 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29.
PubMed 19114462
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Drug-Diet Interactions
- ClinicalTrials.gov ID
- NCT01034124
- Acronym / sponsor ID
- UNC-CH 05-2951
- Conditions
- Pharmacokinetics
- Keywords
- warfarin, midazolam, cranberry juice, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Dec 2009 (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.
Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Drug: warfarin, vitamin K, midazolam |
| Cranberry juice | Active comparator | Drug: warfarin, vitamin K, midazolam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- Healthy
- Not taking medications known to modulate CYP2C9 and CYP3A activity
- Able to understand the consent process
Key exclusion criteria (5 listed)
- Allergy to cranberry products, warfarin, vitamin K, or midazolam
- Pregnant or breast-feeding women
- Baseline INR >1.2
- History of significant medical conditions that could increase risk
- Concomitant medications known to modulate CYP2C9 and CYP3A activity
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 |
|---|---|---|
| warfarin, vitamin K, midazolamAlso: Coumadin, Mephyton, Versedwarfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg) | Drug | Cranberry juice, Water |
Primary outcome
AUC
Time frame: 0-96 hr
1 secondary outcome
Cmax
Time frame: varies
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 17 Dec 2009.
- Results publication: PubMed 19114462Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29.
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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.
Mary F Paine, Ph.D. principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warfarin, vitamin K, midazolam in people with Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 inclusion and 5 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 17 Dec 2009. 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 United States. 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.
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?
AUC (time frame: 0-96 hr). 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 NCT01034124, which also lists 1 linked publication.
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 17 Dec 2009; AzTrials last refreshed its copy on 2 Nov 2026.