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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Bio Pharma Research Inc. — Toronto

Identifiers

NCT: NCT07699120 · RPC25PH101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗