The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - maximum concentration (CMax) for CBD-A
研究概览
简要总结
The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.
详细描述
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of a novel hemp-derived oral cannabinoid product, at various doses, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design. Drug administration will be double blind (the participant and research staff will be unaware of the dose administered). Upon enrollment, participants will complete 4 dosing conditions (placebo, 1 mg/kg, 2 mg/kg, 4 mg/kg of cannabinoids). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic (PK) drug effects. Biological specimens (blood and urine) will be obtained throughout these 8 hours to characterize the pharmacokinetics of CBD, CBD-A, delta-9-Tetrahydrocannabinol (THC), and THC-A, as well as other relevant cannabinoids and metabolites. Pharmacodynamic assessments including subjective drug effects, cognitive performance testing, and vital signs will also be collected for 8 hours post-drug administration. For each of the two days after each experimental session, participants will be asked to return to the lab for brief visits (~20 min) to provide additional biospecimens (~24 and ~48 hrs after dosing) to allow for further PK analysis. These procedures will be completed 4 separate times by each participant (sessions will be separated by at least 1 week to allow for sufficient drug washout between doses).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind (Participant, Outcomes Assessor), placebo controlled
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided written informed consent
- •Be between the ages of 18 and 55
- •Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- •Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session
- •Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session
- •Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission
- •Weigh between 110 lbs (50 kg) and 220 lbs (100 kg)
- •Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- •Self-report prior experience using cannabis or CBD products, but no cannabis, cannabinoid, or hemp product use in the prior 30 days
- •Have not donated blood in the prior 30 days
- •For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last drug administration session
排除标准
- •Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the past 30 days
- •History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures
- •Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant
- •Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
- •History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
- •Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
- •Epilepsy or a history of seizures.
- •Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.
研究组 & 干预措施
Arm 1
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 1mg/Kg (Drug)
Arm 1
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 2mg/Kg (Drug)
Arm 1
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 4mg/Kg (Drug)
Arm 1
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.
干预措施: Placebo CBD (Drug)
Arm 2
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 1mg/Kg (Drug)
Arm 2
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 2mg/Kg (Drug)
Arm 2
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 4mg/Kg (Drug)
Arm 2
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.
干预措施: Placebo CBD (Drug)
Arm 3
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 1mg/Kg (Drug)
Arm 3
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 2mg/Kg (Drug)
Arm 3
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.
干预措施: CBD 4mg/Kg (Drug)
Arm 3
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.
干预措施: Placebo CBD (Drug)
Arm 4
Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.
干预措施: CBD 1mg/Kg (Drug)
Arm 4
Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.
干预措施: CBD 2mg/Kg (Drug)
Arm 4
Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.
干预措施: CBD 4mg/Kg (Drug)
Arm 4
Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.
干预措施: Placebo CBD (Drug)
结局指标
主要结局
Pharmacokinetics - maximum concentration (CMax) for CBD-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - AUC for CBD
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - Tmax for CBD
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - Tmax for THC
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - Tmax for THC-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - AUC for THC-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - Tmax for CBD-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - maximum concentration (CMax) for CBD
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - maximum concentration (CMax) for THC
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - maximum concentration (CMax) for THC-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - AUC for CBD-A
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - AUC for THC
时间窗: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
次要结局
- Number of Correct Trials on the Digit Symbol Substitution Task (DSST)(8 hrs)
- Feel Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)(8 hrs)
- Driving Under the Influence of Drugs (DRUID) application global impairment score(8 hrs)
- Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)(8 hrs)
- Distance from Central Stimulus on the Divided Attention Task (DAT)(8 hrs)