Evaluation of BRC-002 Safety, Tolerability, Pharmacokinetics, and Food Effects in Healthy Participants

Официальное название

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Repeat Dose and Randomized, Open-label, Crossover, Food Effect Safety, Tolerability, and Pharmacokinetic Study of BRC-002 in Healthy Participants

Обзор

This study will evaluate the safety and tolerability of BRC-002, an investigational botanical drug from cannabis, in healthy adults. The study will also assess how the body processes BRC-002 and whether taking it with food affects how it is absorbed or metabolized. The results of this study will help support further clinical development of BRC-002 and guide dose selection in patient populations.

Вмешательства

• Препарат BRC-002
  Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP
• Препарат Placebo
  Oral liquid placebo product manufactured according to cGMP

Первичные конечные точки

• Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants [Срок оценки: Pre-dose up to 144 hours following the final dose]

Вторичные конечные точки (12)

• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Dose-Normalized Maximum Observed Plasma Concentration (Cmax_D) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Time to Maximum Plasma Concentration (tmax) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Dose-Normalized Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast_D) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Dose-Normalized Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf_D) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Apparent Volume of Distribution During the Terminal Elimination Phase (Vd/F) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Apparent Oral Clearance From Plasma (CL/F) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Apparent Elimination Half-Life (t½) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Apparent Terminal Elimination Rate Constant (λz) [Срок оценки: Pre-dose up to 144 hours following the final dose]
• Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity (AUC%extrap) [Срок оценки: Pre-dose up to 144 hours following the final dose]

Критерии участия

Критерии включения

• Male and female volunteers, 18-55 years of age, inclusive.
• Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2, inclusive, and weight ≥50 kg.
• Healthy, according to medical history, ECG, vital signs, laboratory results and physical examination.
• No clinically significant abnormalities in laboratory values.
• Ability to comprehend and be informed of the nature of the study; capable of giving written informed consent prior to any study related procedure.
• Ability to fast for at least 14 hours and consume standard meals and/or high-fat, high-calorie meal, as applicable.
• Agree to avoid use of cannabis or cannabis products for the duration of the study.
• Non-pregnant, non-lactating, and agree to use an approved method of contraception, if applicable.

Критерии исключения

• Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological (including immunocompromising), musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition.
• Personal or significant family history of seizure disorder, neurodegenerative disease, brain trauma, brain infection, or any other condition known to increase the risk of seizures.
• Presence of any clinically significant illness within 30 days prior to first dosing.
• Known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
• Smoking and/or use of any nicotine-containing products (e.g., vapes, e-cigarettes, gum, lozenges, patches, chewing tobacco, oral pouches, etc.) within 6 months prior to study drug administration.
• Positive test result for drugs of abuse (THC, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol, or cotinine.
• Positive pregnancy test for female participants.
• Lifetime history of cannabis dependence.
• Use of cannabis or cannabis products (including hemp or CBD products) within the past 30 days prior to Screening.
• Lifetime history of major psychiatric illness, including schizophrenia, bipolar disorder, generalized anxiety disorder, major depression, panic disorder, substance use disorder, or psychosis.
• Current suicidal ideation or past suicide attempt.
• History of allergy, hypersensitivity, or intolerance to cannabis, CBD, or related products.
• Past significant adverse reaction (allergic, anaphylactic, hypersensitivity, angioedema) or severe response to study drugs, their excipients, and to any other clinically significant drug or food.
• Evidence of significant hepatic impairment as determined by clinically significant abnormalities in laboratory values.
• Known history or presence of alcohol abuse or dependence within one year prior to first study drug administration; drug abuse or dependence; presence of any clinically significant dietary restrictions.
• Abnormal diet patterns during the four weeks preceding the study.
• Intolerance to and/or difficulty with blood sampling through venipuncture.
• Recent blood donation (50-499 mL in the previous 30 days or 500 mL or more in the previous 56 days prior to first study drug administration).
• Recent plasma donation by plasmapheresis (within 7 days prior to first study drug administration).
• Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration.
• Use of any enzyme-modifying drugs and/or other products, including strong inhibitors or inducers of cytochrome P450 (CYP) enzymes in the previous 30 days before first study drug administration.
• Use of any monoamine oxidase (MAO) inhibitors within 30 days prior to first study drug administration.
• Use of clobazam, valproate, or mTOR inhibitors within 30 days prior to first study drug administration.
• Use of any prescription medication or over-the-counter medications (including oral multivitamins, dietary and/or herbal supplements and teas) within 14 days prior to first study drug administration, except for medically acceptable contraceptive products.
• Consumption of food or beverages containing grapefruit, Seville oranges, pineapple and/or pomelo within 10 days prior to first study drug administration.
• Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds, and/or alcohol within 48 hours before dosing.
• Any major surgery within 6 months prior to the start of the study.
• Difficulty with oral drug administration.
• Unable or unwilling to provide informed consent.
• Tattoo or body piercing within 30 days prior to first study drug administration.
• Any other conditions that, in the opinion of the PI/Sub-Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Bio Pharma Research Inc. — Toronto

Идентификаторы

NCT: NCT07699120 · RPC25PH101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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