Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit.
- •The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
- •The participant has ≥2 migraine days and headache occurring on <15 days per month for each month within the past 3 months prior to the Screening Visit.
- •The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m^2) at the Screening Visit.
排除标准
- •The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment.
- •The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- •The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives of that product, whichever is longer, prior to Visit
- •The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- •The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Ubrogepant with Lu AG09222
Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
干预措施: Ubrogepant (Drug)
Ubrogepant with Lu AG09222
Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
干预措施: Lu AG09222 (Drug)
Ubrogepant with Placebo
Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.
干预措施: Ubrogepant (Drug)
Ubrogepant with Placebo
Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to 92 Days
次要结局
- AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity(Predose on Day 1 to Day 12)
- Cmax: maximum observed plasma concentration of ubrogepant(Predose on Day 1 to Day 12)
- tmax: nominal time corresponding to the occurrence of Cmax(Predose on Day 1 to Day 12)
- t½: apparent elimination half-life of ubrogepant(Predose on Day 1 to Day 12)
- Oral Clearance (CL/F) of ubrogepant(Predose on Day 1 to Day 12)
- Apparent volume of distribution (VZ/F) of ubrogepant(Predose on Day 1 to Day 12)
- Number of participants with anti-drug antibodies for Lu AG09222(Up to 92 Days)