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NCT06192589 · ClinicalTrials.gov registry record · Phase 1
Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
A Phase 1 study of Drug Interaction and Drug Induced Liver Injury, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT06192589 is a Phase 1 study of Drug Interaction and Drug Induced Liver Injury that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 241 participants, above the 18-participant average among 3 other Drug Interaction trials with a reported enrollment target (1239% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06192589, a Phase 1 study of Drug Interaction and Drug Induced Liver Injury, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
- 1
- Study location
Study Summary
Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation and drug-induced liver injury has been observed. However, only limited evaluations of the risk of liver enzyme elevation of daily, lower dose CBD use are available. The potential for liver enzyme elevations with lower CBD doses with unapproved consumer products highlights a need for further research. In addition, CBD has the capacity to inhibit cytochrome P450 enzymes and uridine 5'-diphospho-glucuronosyltransferases, leading to potential drug-drug interactions with multiple common medications. The clinical significance of many of these interactions is also unclear. Furthermore, nonclinical studies have suggested the potential for CBD to cause reproductive and endocrine effects. As such, additional high-quality clinical pharmacology studies are needed to further characterize CBD's safety profile. The objective of this study is to characterize the effects of daily CBD use at a dose within the range of what consumers are taking as unapproved CBD products on liver enzyme elevations, drug interactions, and endocrine measures.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol
- DRUG Morphine
- DRUG Citalopram
Study Locations (1)
Wisconsin
- Spaulding Clinical Research - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06192589
The ClinicalTrials.gov registry entry for NCT06192589 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 18-participant average among 3 other Drug Interaction trials with a reported enrollment target (1239% higher). The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Drug Interaction appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06192589 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06192589 about?
NCT06192589 is a clinical study titled "Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions". Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation and drug-induced liver injury has been...
What is the current status of trial NCT06192589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2024-02-08. Estimated completion is 2024-09-06.
What conditions does trial NCT06192589 study?
This clinical trial studies the following conditions: Drug Interaction, Drug Induced Liver Injury, Cannabidiol.
What interventions are being tested in trial NCT06192589?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG), Morphine (DRUG), Citalopram (DRUG).
Who is sponsoring clinical trial NCT06192589?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06192589 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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