A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants.
Ubrogepant and atogepant are approved drugs for treatment of migraine in adults. Participants will be assigned to one of the 2 treatment arms to receive atogepant or ubrogepant. Approximately 24 healthy adult lactating female participants will be enrolled at 3 sites in the United States
Participants will receive oral tablets of ubrogepant or atogepant on Day 1 and will be followed for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, lactating, female volunteers who delivered one or more normal-term infants and established lactation from 1 - 6 months post-partum at the time of enrollment.
- •Had a normal pregnancy (gestation of 37-42 weeks) with no clinically significant complications.
- •Willing to permit the use of pasteurized donor milk, infant formula, or previously pumped/stored human milk to feed the infant.
- •Agree to the use of provided breast pumps for the pumping of breast milk during the milk collection regimen of the study.
排除标准
- •Prior exposure to ubrogepant or atogepant within the past 30 days.
研究组 & 干预措施
Atogepant
Participants will receive single dose of atogepant on Day 1.
干预措施: Atogepant (Drug)
Ubrogepant
Participants will receive single dose of ubrogepant on Day 1.
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 Day 30
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.
Maximum Observed Plasma Concentration (Cmax) of Atogepant
时间窗: Up to Day 2
Cmax of Atogepant
Maximum Observed Plasma Concentration (Cmax)of Ubrogepant
时间窗: Up to Day 2
Cmax of Ubrogepant
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Atogepant
时间窗: Up to Day 2
AUCLST of Atogepant
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCLST) of Ubrogepant
时间窗: Up to Day 2
AUCLST of Ubrogepant
Time to Cmax (Tmax) of Atogepant
时间窗: Up to Day 2
Tmax of Atogepant
Time to Cmax (Tmax) of Ubrogepant
时间窗: Up to Day 2
Tmax of Ubrogepant
Apparent Terminal Phase Elimination Rate Constant (β) of Atogepant
时间窗: Up to Day 2
Apparent terminal phase elimination rate constant of Atogepant
Apparent Terminal Phase Elimination Rate Constant (β) of Ubrogepant
时间窗: Up to Day 2
Apparent terminal phase elimination rate constant of Ubrogepant
Terminal Phase Elimination Half-life (t1/2) of Atogepant
时间窗: Up to Day 2
T1/2 of Atogepant
Terminal Phase Elimination Half-life (t1/2) of Ubrogepant
时间窗: Up to Day 2
T1/2 of Ubrogepant
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Atogepant
时间窗: Up to Day 2
AUCt of Atogepant
AUCt of Ubrogepant
时间窗: Up to Day 2
AUCt of Ubrogepant
AUC From Time 0 to the Time Infinity (AUCinf) of Atogepant
时间窗: Up to Day 2
AUCinf of Atogepant
AUCinf of Ubrogepant
时间窗: Up to Day 2
AUCinf of Ubrogepant
Maximum Observed Breast Milk Concentration (CMAX) of Atogepant
时间窗: Up to Day 2
CMAX of Atogepant
Maximum Observed Breast Milk Concentration (CMAX) of Ubrogepant
时间窗: Up to Day 2
CMAX of Ubrogepant
Time to Maximum Observed Breast Milk Concentration (TMAX) of Atogepant
时间窗: Up to Day 2
TMAX of Atogepant
Time to Maximum Observed Breast Milk Concentration (TMAX) of Ubrogepant
时间窗: Up to Day 2
TMAX of Ubrogepant
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Atogepant
时间窗: Up to Day 2
AUCINF of Atogepant
Area Under the Milk Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCINF) of Ubrogepant
时间窗: Up to Day 2
AUCINF of Ubrogepant
次要结局
未报告次要终点