A Phase 1, Randomized, Open-Label, 2-Period, 2-Sequence, 2-Way Crossover Study to Assess the Effect of Food on the Single Dose Pharmacokinetics of Acoramidis in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
研究概览
简要总结
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation (hematology, chemistry, urinalysis, and coagulation) that are reasonably likely to interfere with the participant's participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator.
- •Body weight ≥ 50 to ≤ 100 kilograms (kg) and body mass index within the range ≥ 18 to < 32 kg/meter squared for all participants.
排除标准
- •Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
- •History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- •History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds. History of allergy to other drugs or food will be evaluated by the Investigator or designee on a case by case basis and a decision to enroll will be made by the Investigator or designee.
- •Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric disease or diseases.
- •Disorders of central nervous system, psychiatric disorders, behavioral disturbances (for example, cerebrovascular events, depression, post-traumatic stress disorder, anxiety, bipolar disorder, severe migraine, Parkinson's disease).
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to the first dose of study intervention.
- •Female participants who are pregnant, as evidenced by a positive serum pregnancy test result at Screening, or breastfeeding.
- •Prior exposure to ALXN
- •Major surgery or hospitalization within 90 days prior to dosing on Day
- •Use of tobacco in any form (for example, smoking, chewing or vaping), other nicotine-containing products in any form (for example, gum, patch, electronic cigarettes, or vapes), or any recreational inhalational product within 6 months prior to the planned first day of dosing.
- •Use of known drugs of abuse within 6 months prior to the planned first day of dosing.
- •Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of > 14 units/week for males or > 7 units/week for females. One unit is equivalent to 8 grams of alcohol: a half pint (~240 milliliters [mL]) of beer, one ~4 ounce glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
- •Positive urine drug toxicology screen at Screening or check-in (Day -1).
- •Alcohol consumption within 24 hours prior to study intervention administration or positive alcohol breath test at Screening or check-in (Day -1).
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study.
研究组 & 干预措施
Sequence 1: Acoramidis
Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows:
Period 1: Acoramidis as an immediate-release tablet under fasted conditions.
Period 2: Acoramidis as an immediate-release tablet under fed conditions.
There will be a washout period of at least 14 days between acoramidis dosing.
干预措施: Acoramidis (Drug)
Sequence 2: Acoramidis
Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows:
Period 1: Acoramidis as an immediate-release tablet under fed conditions.
Period 2: Acoramidis as an immediate-release tablet under fasted conditions.
There will be a washout period of at least 14 days between acoramidis dosing.
干预措施: Acoramidis (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
时间窗: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
时间窗: Up to 336 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Zero To Infinity (AUC0-inf) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions
时间窗: Up to 336 hours postdose
次要结局
- AUC0-t For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions(Up to 336 hours postdose)
- AUC0-inf For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions(Up to 336 hours postdose)
- Cmax Of Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions(Up to 336 hours postdose)