A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
研究概览
简要总结
The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).
- •Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
- •Have a hemoglobin level of
- •at least 11.4 g/dL for individuals assigned female at birth (AFAB) and
- •at least 12.5 g/dL for AMAB.
- •Have venous access sufficient to allow for blood sampling.
排除标准
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.
- •Have an abnormal 12-lead electrocardiogram (ECG).
- •Have human leucocyte antigen-B (HLA-B)*1502 or HLA-A*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.
- •Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.
- •Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.
研究组 & 干预措施
Orforglipron + Carbamazepine
Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally
干预措施: Carbamazepine (Drug)
Orforglipron + Carbamazepine
Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally
干预措施: Orforglipron (Drug)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
时间窗: Predose up to Day 18
PK: AUC (0-tlast) of Orforglipron
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron
时间窗: Predose up to Day 18
PK: AUC (0-∞) of Orforglipron
PK: Maximum Observed Concentration (Cmax) of Orforglipron
时间窗: Predose up to Day 18
PK: Cmax of Orforglipron
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron
时间窗: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)
PK: AUC (0-∞) of Orforglipron
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
时间窗: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)
PK: AUC (0-tlast) of Orforglipron
PK: Maximum Observed Concentration (Cmax) of Orforglipron
时间窗: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)
PK: Cmax of Orforglipron
次要结局
未报告次要终点