A Phase 1, Single-Center, Open-Label, 3-Cohort, Fixed-Sequence, Drug-Drug Interaction Study To Assess The Pharmacokinetics Of LY4100511 (DC-853) When Orally Administered Alone, When Coadministered With Itraconazole, Fluconazole, Or Carbamazepine In Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)
研究概览
简要总结
The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)
- •Males who agree to follow contraceptive requirements and women of not childbearing potential
- •Have body weight greater than or equal to (>=) 50 Kilograms at screening.
- •Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening
- •Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site
- •Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site
- •Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site
排除标准
- •Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study
- •Females participants who are currently breastfeeding
- •Have History of alcohol abuse or drug addiction
- •Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site
- •Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies
- •Consumption of any nutrients known to modulate CYP450 enzymes activity
- •Are immunocompromised
- •Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study
- •Have had any malignancy within the past 5 years
研究组 & 干预措施
LY4100511 (DC-853) + Itraconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
干预措施: Itraconazole (Drug)
LY4100511 (DC-853) + Itraconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) + Fluconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) + Fluconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
干预措施: Fluconazole (Drug)
LY4100511 (DC-853) + Carbamazepine
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) + Carbamazepine
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)
时间窗: Predose up to 26 Days
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)
时间窗: Predose up to 26 Days
PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)
时间窗: Predose up to 26 Days
次要结局
未报告次要终点