NCT03635879撤回1 期
A Phase 1, Single-Center, Pilot, Single-Dose, 6-Way Crossover Study to Compare Six Formulations of Medium Chain Triglycerides on the Pharmacokinetics of Ketone Body Production
Cerecin0 个研究点开始时间: 2019年2月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- B-hydroxybutyrate
研究概览
简要总结
This is a Phase I, open label, randomized, 6-way crossover, pilot PK study
详细描述
12 healthy, male subjects enrolled, subject will be randomized to receive a single dose of one of six treatment, with a 2 day washout in between each dosing period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male 18 55 years of age, inclusive, at Screening.
- •Continuous non smoker who has not used nicotine containing products for at least 3 months prior to Day -1 of Period 1 and throughout the study based on self-reporting.
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee. At screening, subjects must have alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ the upper limit of normal and triglyceride levels must be < 250 mg/dL.
- •Hemoglobin levels ≥ the lower limit of normal at Screening and Day -1 of Period
- •A non vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Day -1 of Period
- •A subject who has been vasectomized less than 4 months prior to Day -1 of Period 1 must follow the same restrictions as a non vasectomized male).
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
排除标准
- •Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •History or presence of alcoholism or drug abuse within the past year prior to Day -1 of Period
- •History or presence of galactosemia or hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy.
- •History or presence of symptomatic diverticular disease, uncontrolled gastroesophageal reflux disease, ulcers, inflammatory bowel disease, irritable bowel syndrome or recurrent diarrhea, or gout.
- •Positive urine drug results at Screening or Check-in.
- •Positive alcohol results at Screening or Check-in. One repeat assessment is permitted.
- •Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- •Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening. One repeat assessment is permitted.
- •Seated heart rate is lower than 40 bpm or higher than 99 bpm at Screening.
- •QTcF interval is >460 msec or subject has ECG findings deemed abnormal with clinical significance by the PI or designee at Screening.
- •Estimated creatinine clearance ≤ 80 mL/min at Screening.
- •Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to Day -1 of Period 1 and throughout the study. Acetaminophen (up to 2 g per 24 hours) may be permitted during the study.
- •Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 28 days prior to Day -1 of Period 1 and throughout the study.
- •Has been following a ketogenic diet, in the opinion of the PI or designee, within 2 weeks prior to Day -1 of Period
- •Is lactose intolerant.
- •Is unable to complete the standard breakfast prior to dosing on Day 1 of each Period.
- •Donation of blood or significant blood loss within 56 days prior to Day -1 of Period
- •Plasma donation within 7 days prior to Day -1 of Period
- •Participation in another clinical study within 28 days prior to Day -1 of Period
- •The 28-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day -1 of Period 1 of the current study.
研究组 & 干预措施
MCTprocal medical food
Active Comparator
Vitaflo MCTprocal, single dose (20 g MCT)
干预措施: MCTprocal medical food (Other)
Milk/tricaprilin oil blend
Active Comparator
Lactose-free milk and tricaprilin oil, blended,single dose (20 g tricaprilin)
干预措施: Milk/tricaprilin oil blend (Other)
AC-1207
Active Comparator
AC-1207 liquid, single dose (20 g tricaprilin)
干预措施: AC-1207 (Other)
AC-1205
Active Comparator
AC-1205 liquid, single dose (20 g tricaprilin)
干预措施: AC-1205 (Other)
AC-1206
Active Comparator
AC-1206 liquid, single dose (20 g tricaprilin)
干预措施: AC-1206 (Other)
AC-1202
Experimental
AC-1206 liquid, single dose (20 g tricaprilin)
干预措施: AC-1202 (Drug)
结局指标
主要结局
B-hydroxybutyrate
时间窗: 1 day
Cmax
Total ketones
时间窗: 1 day
Maximum Plasma Concentration (Cmax)
Acetoacetate
时间窗: 1 day
Cmax
次要结局
未报告次要终点
研究者
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