Status:
WITHDRAWN
DHB Supplement Interaction Study
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Brief Summary
Background: \- 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 ...
Detailed Description
6 ,7 -dihydroxybergamottin (DHB) is one of the components of grapefruit juice and is a known irreversible inhibitor of intestinal cytochrome P450 3A (CYP3A). A single serving (240 mL) of grapefruit ju...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18-60
- Men and non-pregnant women
- Participant in the Environmental Polymorphisms Registry. Prior to enrollment in this study the participant will be required to enroll in the -Environmental Polymorphisms Registry.
- Willing to abstain from fruit juices, star fruit, grapefruit and grapefruit-related fruits (e.g., pomelo, Seville orange), and grapefruitcontaining products for 1 week prior to Exposure Visits and for the 4 follow-up visits.
- Willing to fast (with the exception of water) from midnight prior to the screening visit and each Exposure Visit, including abstaining from
- alcohol and caffeinated beverages
- Ability to successfully complete treatment visits, including securing transportation
- EXCLUSION CRITERIA:
- Women who are currently pregnant or breastfeeding
- Current use of known CYP3A inhibitors or inducers, which in the opinion of the Investigator poses an unacceptable risk to the patient or to the validity of study results. Candidates will be asked about medication use during the screening process and on the day of the exposure visits. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
- Known liver dysfunction or disease as defined by:
- ALT - higher than the normative value and/or determined abnormal by the PI
- AST higher than the normative value and/or determined abnormal by the PI
- ALP higher than the normative value and/or determined abnormal by the PI
- Known kidney dysfunction or disease or:
- Estimated Glomerular Filtration Rate (eGFR)- \<60 ml/min per the MDRD equation
- Heart disease
- Pre-existing and known history of psychiatric disorders
- Known history of Myasthenia gravis
- Current use of quinidine, ritonavir, and saquinavir (potential interaction with loperamide)
- Current use of study drug-related medications (benzodiazepines, opioids, herbal supplements; temporary discontinuation per the investigator s discretion may be allowed). Candidates will be asked about medication use during the screening process and also during each of their exposure visits. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
- Known allergy or hypersensitivity to any study treatments (i.e., to GFJ, DHB, midazolam, loperamide, green, black or white pepper, and -Indian Gooseberry),any opioids, or benzodiazepines
- History of acute-angle glaucoma
- History of sleep apnea
- Current diagnosis of anemia, as defined by hemoglobin concentration \<13 g/dL for males and hemoglobin concentration \<11 g/dL for females or hematocrit values (determined by lancet-induced drop of blood from the fingertip or via clinical labs) Hematocrit must be at least 34% for women and 36% for men on every visit.
- Blood donation within the past 8 weeks of the exposure visit.
- Use of medications for which consumption of GFJ is contraindicated and which in the opinion of the Investigator would pose an unacceptable risk to the patient if discontinued or continued while consuming GFJ. Candidates will be asked about medication use during the screening process. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
- Any other conditions or substance use that in the opinion of the Investigator would pose an unacceptable risk to the patient or to the validity of the study results. Candidates will be asked about health conditions during the screening process. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
- BMI \>35.
Exclusion
Key Trial Info
Start Date :
October 3 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02257879
Start Date
October 3 2014
End Date
April 20 2020
Last Update
April 24 2020
Active Locations (1)
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1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States