NCT05794243终止1 期
An Open-Label, Multiple-Dose Study to Investigate the Pharmacokinetics of LY3493269 Oral Formulations Administered in a Fed or Fasted State in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269
研究概览
简要总结
The main purpose of this study is to conduct blood tests to measure how much LY3493269 is in the bloodstream and how the body handles and eliminates LY3493269 when administered orally as test compared to reference formulations in healthy participants in fed and/or fasted states. The study will also evaluate the safety and tolerability of LY3493269 in these participants. The study will last up to 43 days excluding the screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants who are overtly healthy as determined by medical evaluation
- •Participants with body mass index (BMI) of 19.0 to 40.0 kilograms per meter squared (kg/m²)
- •Males who agree to use highly effective/effective methods of contraception and only women not of childbearing potential may participate in the trial
排除标准
- •Have a history of atopy (severe or multiple allergic manifestations) or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis)
- •Have a significant history of or current cardiovascular (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, gastrointestinal (GI) including involving the liver, gallbladder or gallbladder surgery, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the investigational product (IP); or of interfering with the interpretation of data.
- •Have a mean supine heart rate (HR) less than 45 bpm or greater than 100 bpm from 2 assessments at screening.
- •Have a mean supine systolic blood pressure (BP) higher than 160 mmHg and a mean supine diastolic BP higher than 95 mmHg from 2 assessments at screening
- •Have undergone any form of bariatric surgery.
- •Have a history of GI bleeding, or gastric or duodenal ulcers.
- •Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN).
- •Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
- •Have evidence of significant active neuropsychiatric disease as determined by the investigator.
- •Have been treated with prescription drugs that promote weight loss within 3 months prior to screening.
- •Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have participated within the past 30 days of screening in a clinical study involving an IP; at least 5 half-lives or 30 days, whichever is longer, should have passed.
- •Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QT interval corrected using Fridericia's formula (QTcF) >450 msec for males and >470 msec for females, short PR interval (<120 msec), or PR interval >220 msec, second- or third-degree atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome.
- •Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5x ULN or total bilirubin level (TBL) >1.5x ULN.
- •Show evidence of human immunodeficiency virus infection and/or positive human immunodeficiency virus antibodies.
- •Show evidence of hepatitis C and/or positive hepatitis C antibody.
- •Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen.
研究组 & 干预措施
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
Experimental
- Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10).
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: LY3493269 (Drug)
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
Experimental
- Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10).
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: Sodium Caprate (C10) (Drug)
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
Experimental
- Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: LY3493269 (Drug)
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
Experimental
- Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: Sodium Caprate (C10) (Drug)
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
Experimental
- Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC).
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: LY3493269 (Drug)
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
Experimental
- Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC).
- This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
干预措施: Salcaprozate Sodium (SNAC) (Drug)
Part B: LY3493269
Experimental
The formulation of the LY3493269 test capsule (1,2) or reference tablet were planned to be determined based on the initial review of safety and pharmacokinetic data from Part A.
干预措施: LY3493269 (Drug)
结局指标
主要结局
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269
时间窗: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose
PK: AUC (0-∞) of LY3493269
Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3493269
时间窗: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose
PK: AUCτ of LY3493269
Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
时间窗: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose
Cmax of LY3493269
次要结局
未报告次要终点
研究者
研究点 (1)
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