NCT07439250已完成1 期
A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib
研究概览
简要总结
The main purpose of this study in healthy participants is to determine the effect of fluconazole on the amount of study drug that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 7 weeks and will require 12 overnight stays in the research center.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Must have a Body Mass Index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2)
- •Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
排除标准
- •History or presence of the following conditions:
- •metabolic disease
- •biliary disease
- •gastrointestinal disease
- •hematological disease
- •neurological disease
- •significant history of hepatic disease
- •clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to Day 1
- •Abnormal blood pressure or pulse rate
- •Have a 12-lead electrocardiogram (ECG) abnormality, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG analysis
- •History of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix, that have been resected with no evidence of metastatic disease for 3 years.
- •Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies
- •Have a positive hepatitis C antibody test
- •Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA), or both.
- •Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation
- •Use of tobacco, smoking-cessation products, electronic (e)-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to first olomorasib administration and through the end of trial
研究组 & 干预措施
Olomorasib + Fluconazole
Other
Administered orally
干预措施: Fluconazole (Drug)
Olomorasib + Fluconazole
Other
Administered orally
干预措施: Olomorasib (Drug)
Olomorasib
Other
Administered orally
干预措施: Olomorasib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib
时间窗: Baseline, Day 12
PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
时间窗: Baseline, Day 12
PK: Cmax of Olomorasib
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept TrialNCT07295314Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)50
已完成
1 期
A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine)NCT07335419Pfizer12
已完成
3 期
A randomized controlled clinical trial on effect of topical clotrimazole vs. topical fluconazole vs. topical application of gentian violet in the treatment of otomycosis conducted in a tertiary health care centreCTRI/2024/05/067969K J Somaiya Medical College and Hospital100
招募中
1 期
A study in healthy people to test how itraconazole influences the amount of BI 3031185 in the blood2025-520654-10-00Boehringer Ingelheim International GmbH14
尚未招募
不适用
Mechanism of antibiotic(Fluconazole) resistance for Non- Candida speciesCTRI/2024/04/066326Datta Meghe Institute of Higher Education and Research78