DHB Supplement Interaction Study
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|ClinicalTrials.gov Identifier: NCT02257879|
Recruitment Status : Withdrawn (due to constraints with collaborator and subject matter expert, recruitment was unable to begin)
First Posted : October 7, 2014
Last Update Posted : April 24, 2020
- Drinking grapefruit juice changes how long it takes some medicines to be broken down in the body. Researchers have found that a substance in grapefruit juice called DHB contributes to this effect. Some dietary supplements contain DHB and claim to increase the absorption of any and all supplements, medicine or any other drug. But these usually contain a lot more DHB than a glass of grapefruit juice. Researchers want to study the effects of grapefruit juice and supplements with DHB.
- To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice affects how long it takes a person s body to break down medicines.
- Healthy volunteers ages 18 - 60.
- Participants will be screened with medical history, physical exam, and blood and urine tests.
- Participants will have 3 treatment visits. Participants cannot drive themselves home from the visits. Each visit lasts about 13.5 hours and includes:
- Questions about medications and participant s health.
- Vital signs taken.
- A finger probe to measure oxygen.
- Blood and urine sampling throughout the visit.
- An IV line inserted into an arm vein. It will stay there throughout the visit.
- Study treatments:
- Midazolam hydrochloride a syrup given to make people sleepy.
- Loperamide a tablet for treating diarrhea.
- 1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one will be given at each treatment visit.
- One week before each visit, participants cannot have certain fruits and juices. They must fast the night before each visit.
- For the 3 days after each visit, participants will return to the clinic 4 times. Their vital signs will be checked and blood will be drawn.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Pharmacokinetic Study to Assess and Compare the Drug Interaction Risk of the Grapefruit Juice and Dietary Supplements Known to Inhibit CYP3A Enzyme Activity|
|Actual Study Start Date :||October 3, 2014|
|Actual Primary Completion Date :||April 20, 2020|
|Actual Study Completion Date :||April 20, 2020|
water - GFJ - supplement
GFJ - supplement - water
supplement - water - GFJ
- Pharmacokinetic measures (AUC0 inf, Cmax) of systemic drug exposure [ Time Frame: AUC from 0-72 h -inf ]PK measures of systemic probe drug exposure (AUCO-inf and Cmax), determined via conventional non-compartmental methods using Phoenix WinNonlin (v6.2)
- Geometric means, estimates of treatment differences, within-subject and between-subject treatment variance, and the 95% confidence intervals around those estimates [ Time Frame: AUC from 0-72 h -inf ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257879
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)|
|Research Triangle Park, North Carolina, United States|
|Principal Investigator:||Shepherd H Schurman, M.D.||National Institute of Environmental Health Sciences (NIEHS)|