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INTERVENTIONALENROLLING BY INVITATIONNCT07699120
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
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-07-13
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE1
- Enrollment
- 50 (ESTIMATED)
- Start date
- 2026-06-15
- Sponsor
- Biopharmaceutical Research Company
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 1
- Results record
- Not present in registry snapshot
Healthy Adult ParticipantsbotanicalcannabisBRC-002botanical drugcannabinoid
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGBRC-002
Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP
botanical drug from cannabisDRUGPlacebo
Oral liquid placebo product manufactured according to cGMP
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Accepted
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.
primary outcomes
primary 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
Incidence of adverse events, including serious AEs and AEs of special interest. Clinically significant changes in clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.
secondary outcomes
secondary measures
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose up to 144 hours following the final dose
Maximum observed plasma concentration of BRC-002 following administration
Dose-Normalized Maximum Observed Plasma Concentration (Cmax_D)
Time frame: Pre-dose up to 144 hours following the final dose
Maximum observed plasma concentration of BRC-002 normalized to the administered dose
Time to Maximum Plasma Concentration (tmax)
Time frame: Pre-dose up to 144 hours following the final dose
Time from dosing to the maximum observed plasma concentration of BRC-002
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
Area under the plasma concentration-time curve of BRC-002 from time zero to the last quantifiable concentration
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 of BRC-002 from time zero to the last quantifiable concentration, normalized to the administered 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
Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity
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
Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity, normalized to the administered dose
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 7a7f4cdf-a7a9-4241-a74b-e5cfe9072970
- Retrieved
- 11/09/2026, 14:16:58
- SHA-256
- 14a735cae499c069e38d530a2b810540edf8aa9325ca63cf5ede1cd9326bcbfa
Apparent Volume of Distribution During the Terminal Elimination Phase (Vd/F)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent volume of distribution of BRC-002 during the terminal elimination phase following extravascular administration
Apparent Oral Clearance From Plasma (CL/F)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent clearance of BRC-002 from plasma following extravascular administration
Apparent Elimination Half-Life (t½)
Time frame: Pre-dose up to 144 hours following the final dose
Time required for the plasma concentration of BRC-002 to decrease by half during the terminal elimination phase
Apparent Terminal Elimination Rate Constant (λz)
Time frame: Pre-dose up to 144 hours following the final dose
Terminal elimination rate constant of BRC-002 estimated from the terminal log-linear portion of the plasma concentration-time curve
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
Percentage of the total area under the plasma concentration-time curve of BRC-002 from time zero to infinity that is extrapolated from the last quantifiable concentration to infinity
Maximum Observed Plasma Concentration (Cmax) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Maximum observed plasma concentration of BRC-002 following administration under fasted and fed (high-fat/high-calorie meal) conditions
Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Area under the plasma concentration-time curve of BRC-002 from time zero to the last quantifiable concentration following administration under fasted and fed (high-fat/high-calorie meal) conditions
Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity following administration under fasted and fed (high-fat/high-calorie meal) conditions
Time to Maximum Plasma Concentration (tmax) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Time from dosing to the maximum observed plasma concentration of BRC-002 following administration under fasted and fed (high-fat/high-calorie meal) conditions
Apparent Elimination Half-Life (t½) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Time required for the plasma concentration of BRC-002 to decrease by half during the terminal elimination phase following administration under fasted and fed (high-fat/high-calorie meal) conditions
Apparent Terminal Elimination Rate Constant (λz) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Terminal elimination rate constant of BRC-002 estimated from the terminal log-linear portion of the plasma concentration-time curve following administration under fasted and fed (high-fat/high-calorie meal) conditions