A Phase 1 Study to Investigate the Effect of LY3437943 on the Pharmacokinetics of the Combined Oral Contraceptive Ethinyl Estradiol and Drospirenone in Female Participants

Eli Lilly and Company2 个研究点分布在 1 个国家目标入组 46 人开始时间: 2023年9月12日最近更新: 2024年7月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 46
试验地点: 2
主要终点: PK: Time of Maximum Observed Concentration (Tmax) of Ethinyl Estradiol

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 40 Years 至 60 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Postmenopausal female participants
•Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)

排除标准

•Have an unstable disease or a disease constituting a risk when taking the study intervention.
•Have significant renal insufficiency
•Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery.
•Have a history or presence of chronic or idiopathic acute pancreatitis.
•Have a history of severe clinically significant multiple or severe drug allergies.
•Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
•Have had any malignancy within the past 5 years 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
•Have any form of diabetes mellitus other than type 2
•Have type 2 diabetes with HbA1c greater than or equal to 10% at screening
•Have received an oral or transdermal patch hormone replacement therapy (HRT) within the last 1 month prior to screening or depot injectable HRT within the last 6 months
•Have received any investigational drug within the last month or 5 half-lives of this drug, whichever is longer, prior to screening. If the half-life of the previous investigational drug is unknown, the washout period should be at least 3 months before screening
•Show evidence of HIV infection or positive HIV antibodies
•Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a confirmatory test for hepatitis C virus RNA is negative
•Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test was also performed recently and is positive, the participant should be excluded independently of the hepatitis B surface antigen test result. The hepatitis B core antibody test is not used to assess eligibility
•Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or with significant abnormalities in laboratory liver tests
•Have a fasting triglyceride level greater than 500 mg/dL at screening
•Used any nicotine product including tobacco or nicotine replacement products within 1 month prior to screening or a positive cotinine test at screening. Are unable or unwilling to refrain from using such products during the study
•Have donated at least 450 mL of blood within 8 weeks before screening or intend to donate blood during the study

研究组 & 干预措施

LY3437943 + Combined Oral Contraceptive (COC)

Experimental

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

干预措施: LY3437943 (Drug)

LY3437943 + Combined Oral Contraceptive (COC)

Experimental

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

干预措施: Ethinyl Estradiol (Drug)

LY3437943 + Combined Oral Contraceptive (COC)

Experimental

The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC).

干预措施: Drospirenone (Drug)