Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus (NCT05490511) | Clinical Trial Compass
CompletedPhase 1
Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus
United States57 participantsStarted 2022-10-31
Plain-language summary
The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-75
* Are judged healthy enough to participate as determined by and decided from a pre-enrollment screening session that includes medical history and laboratory tests such as blood and urine tests, and electrocardiography (EKG).
* Agree to refrain from taking any prescription medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of the study drugs at least 2 weeks prior to the start of the study and until study completion.
* Are willing to commit the time requested for this study
* Are willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study (the entire study lasts for approximately 26 days).
Additional Criteria for the Healthy volunteer study:
• Have a GFR above 60 ml/min/1.73m2 with proteinuria less than 0.3 grams by urine protein to creatinine ratio or 24 hour urine collection
Additional Criteria for the CKD study:
* Have either:
* A GFR less than or equal to 60 ml/min/1.73m2 or
* The presence of greater than 0.3 grams of proteinuria by urine protein to creatinine ratio or 24 hour urine collection, but less than 3.5 gm of nephrotic range proteinuria as hypoalbuminemia may impact protein binding.
Exclusion Criteria:
* Unable to provide informed consent
* Have history of intolerance, allergic reactions (e.g. rash) or other forms of hypersensitivities to any of the study medications (tacrolim…
What they're measuring
1
The AUC0-Infinity ratio of tacrolimus with cannabidiol divided by tacrolimus alone