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Cannabinoid

CBD Pharmacokinetics in Healthy Subjects

Phase 1
Waitlist Available
Led By Yasmin Hurd
Research Sponsored by Hurd,Yasmin, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the cbd capsules.
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of CBD in healthy individuals to see if it is safe and affects them pharmacologically.

Who is the study for?
This trial is for healthy adults aged 18-65 who speak English, are not using any medications or drugs (including nicotine), and have normal liver function. They must use effective contraception if applicable. Pregnant or breastfeeding individuals, those with a history of drug abuse or certain medical conditions, and anyone participating in another drug trial recently cannot join.
What is being tested?
The study is testing the safety and how the body processes cannabidiol (CBD) in healthy people. It's an open cross-over design which means participants will receive CBD at some point during the study to compare different ways it can be administered.
What are the potential side effects?
While specific side effects aren't listed, potential risks may include allergic reactions to cannabinoids or other ingredients like gelatin/sesame oil used in the product formulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the cbd capsules.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the cbd capsules. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration curve (AUC)
Peak plasma concentration (Cmax)
Safety and adverse effects
Secondary study objectives
Area under the urine concentration curve (AUC)
Peak urine concentration of CBD (Umax)

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
29%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Test condition 4Experimental Treatment1 Intervention
Cannabidiol 400 mg with high fat meal
Group II: Test condition 3Experimental Treatment1 Intervention
Epidiolex 400 mg with standard meal
Group III: Test condition 2Experimental Treatment1 Intervention
Cannabidiol 400 mg with standard meal
Group IV: Test condition 1Experimental Treatment1 Intervention
Cannabidiol 200 mg with standard meal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hurd,Yasmin, Ph.D.Lead Sponsor
5 Previous Clinical Trials
433 Total Patients Enrolled
Yasmin HurdPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05023070 — Phase 1
Healthy Subjects Research Study Groups: Test condition 1, Test condition 2, Test condition 3, Test condition 4
Healthy Subjects Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05023070 — Phase 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023070 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05023070 — Phase 1
~6 spots leftby Dec 2025
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