A Two-Part, Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability (Versus Immediate Release Tablet) and Food Effect of a New Orally Disintegrating Tablet Formulation of Ubrogepant in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.
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
- •BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
排除标准
- •History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, neurologic, or psychiatric disease or disorder, history of Raynaud's Phenomenon, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food.
研究组 & 干预措施
Ubrogepant-Part 2-Dose D
Participants will receive a single oral dose D of ubrogepant on Day 1 under fed conditions.
干预措施: Ubrogepant (Drug)
Ubrogepant-Part 1-Dose A
Participants will receive a single oral dose A of ubrogepant on Day 1 under fasting conditions.
干预措施: Ubrogepant (Drug)
Ubrogepant-Part 1-Dose B
Participants will receive a single oral dose B of ubrogepant on Day 1 under fasting conditions.
干预措施: Ubrogepant (Drug)
Ubrogepant-Part 2-Dose C
Participants will receive a single oral dose C of ubrogepant on Day 1 under fasting conditions.
干预措施: Ubrogepant (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 33 days
An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of Ubrogepant
时间窗: Up to approximately 3 days
AUCt of Ubrogepant
AUC From Time 0 to the Time Infinity (AUCinf) of Ubrogepant
时间窗: Up to approximately 3 days
AUCinf of Ubrogepant
Maximum Observed Plasma Concentration (Cmax) of Ubrogepant
时间窗: Up to approximately 3 days
Cmax of Ubrogepant
Time lag between dosing and drug to appear in systemic circulation following extravascular administration (Tlag) of Ubrogepant
时间窗: Up to approximately 3 days
Tlag of Ubrogepant
Time to maximum observed plasma concentration (Tmax) of Ubrogepant
时间窗: Up to approximately 3 days
Tmax of Ubrogepant
Apparent terminal phase elimination constant (λz) of Ubrogepant
时间窗: Up to approximately 3 days
λz of Ubrogepant
Terminal phase elimination half-life (t1/2) of Ubrogepant
时间窗: Up to approximately 3 days
t1/2 of Ubrogepant
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Ubrogepant
时间窗: Up to approximately 3 days
CL/F of Ubrogepant
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Ubrogepant
时间窗: Up to approximately 3 days
Vz/F of Ubrogepant
次要结局
未报告次要终点