A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication (METAL-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Intoxication
研究概览
简要总结
This will be a (2 visit) double-blind, randomized, placebo crossover design clinical study to assess the potential benefits of FSD-F2R6-A-CP versus a placebo by assessing its impact on side effect profiles as well as cognitive abilities, motor abilities, and breath alcohol concentration following ingestion of alcohol followed by the dietary supplement or placebo. This study will enroll healthy men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-literate, non-smoking (> 6 months),
- •Men and women aged 25 to 45 years,
- •Body mass index (BMI) of 18.5 to 32.0 kg/m2, and weighing between 110 and 220 lbs (50-100 kg).
- •Free of the diseases listed in exclusion criteria according to their medical history,
- •An ECG value of ≤ 440 msec for males and ≤ 460 msec for females, as measured by an FDA-cleared ECG device (6-lead device, KardiaMobile), administered by the investigator.
- •Capable of consuming 4-6 standard drinks for women or 5-7 standard drinks for men on a single occasion without experiencing moderate sedation, vomiting, or aggression, to be eligible for the study. Moderate sedation is defined as the subject must be able to communicate and follow simple directions following the consumption of indicated number of drinks.
- •Agree not to get tattoos or body piercings, or receive vaccines during the study period, or 7 days prior to the study period.
- •Female subjects who must test negative on a urine pregnancy test, and cannot be pregnant or lactating. All subjects are required to either refrain from sex or use at least one form of contraception throughout the study, including a condom or either an oral or intrauterine contraceptive.
- •Men who must agree not to donate sperm for 90 days following the trial.
- •Experienced at least 2 hangovers
- •Clinical laboratory values within the most recent acceptable laboratory test range, and/or values are deemed by the Investigator /Sub-Investigator as "Not Clinically Significant" as per CBC/CMP, urinalysis, and coagulation testing.
排除标准
- •A known history or presence of any clinically relevant conditions affecting the liver, kidneys, gastrointestinal system, cardiovascular system, cerebrovascular system, lungs, endocrine system, immune system, musculoskeletal system, nervous system, psychiatric state, respiratory system, skin, or blood, unless deemed not clinically significant by the Investigator/Sub-Investigator. This includes a significant history or current issues with gastrointestinal pathology, such as chronic diarrhea or inflammatory bowel diseases, or conditions affecting drug absorption, distribution, metabolism, or excretion
- •Major surgery within the past 6 months, a history of seizures, significant head trauma, or neurosurgery, or any clinically significant illness within 30 days prior to dosing are also excluded
- •Are on a ketogenic or very low carbohydrate diet within the past 30 days.
- •Significant physical or organ abnormalities, a positive screening for a HIV, Hepatitis B or C (as determined by medical health questionnaires), or positive test result for drugs with abuse potential (cannabis, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines)
- •Alcohol-naïve
- •Positive pregnancy test
- •A history of significant alcohol sensitivity
- •A history of adverse reactions to power (energy) drinks or caffeine,
- •Severe food allergies, or dietary restrictions.
- •Allergic reactions to any ingredients in the FSD-F2R6-A-CP and placebo.
- •A psychiatric history of certain disorders, a first-degree relative with specific psychiatric or alcohol use disorders,
- •An intolerance to blood sampling, recent blood or plasma donations within the past 60 days.
- •Recently used enzyme-modifying drugs within the previous 30 days including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John's Wort, and rifampicin).
- •Current or past history within the last 2 years of alcohol or drug dependence (excluding caffeine and nicotine).
- •Current or past history within the last 5 years of major depressive disorder, obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa. First-degree relative with current or historical Alcohol Use Disorder (AUD).
- •Intolerance to and/or difficulty with blood sampling through venipuncture or indwelling catheter.
- •Used of prescription medication (other than contraception or occasional paracetamol) or over-the-counter medications including supplements within 14 days prior to session 1,
- •A positive alcohol test at check-in on treatment day,
- •Recent tattoos or piercings (within 7 days of study enrollment)
- •Any condition deemed by the Investigator or Sponsor to interfere with study participation will be excluded.
结局指标
主要结局
Intoxication
时间窗: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Intoxication will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of intoxication.
Impairment
时间窗: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Impairment will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of impairment.
Mental Fatigue
时间窗: Change in pre-treatment score to 0.5, 1, 2 and4 hours post-treatment
Mental fatigue will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of mental fatigue.
Clearheaded-Muzzy
时间窗: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Clearheaded-Muzzy will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Clumsy-Well Coordinated
时间窗: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Clumsy-Well Coordinated will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Energetic-Lethargic
时间窗: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
Energetic-Lethargic will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Drowsy-Alert
时间窗: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
Drowsy-Alert will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Mentally Slow-Quick Witted
时间窗: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Mentally Slow-Quick Witted will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Headache
时间窗: Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment
Headache will be measured on a 100 mm VAS. The subject will indicate the severity of any headache by drawing a vertical line on the horizontally positioned VAS. The left end (0 mm) of the VAS will designate 'no pain' and the right end (100mm) will designate 'most severe pain imaginable' with no intermediate divisions or descriptive terms.
次要结局
- Digital Symbol Substitution Task (DSST)(Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment)
- Druid App Test(Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment)
- Trail Making Test (TMT)(Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment)
- Breath Alcohol Concentration(Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment)
- Acute Hangover Severity Scale (AHSS)(Measured at 8 and 24 hours after treatment)
- Single Item Hangover Severity Score(Measured at 8 and 24 hours after treatment)
- Systolic blood pressure(Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment)
- Diastolic blood pressure(Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment)
- Heart rate(Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment)
- Respiratory rate(Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment)
- Temperature(Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment)