A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening
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
- Double (Participant, Investigator)
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
- •Are male or female not of childbearing potential
- •Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
- •Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
- •Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
- •Have venous access sufficient to allow blood sampling as per the protocol.
排除标准
- •Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, 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 IP; or of interfering with the interpretation of data
- •Have undergone any form of bariatric surgery
- •Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- •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 investigational product (IP); at least 5 half-lives or 30 days, whichever is longer, should have passed
- •Have an abnormality in the 12-lead 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 QTcF greater than (>) 450 milliseconds (msec) for males and > 470 msec for females, short PR interval (< 120 msec), or PR interval > 220 msec, second and third 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) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
- •Show evidence of HIV infection and/or positive human HIV 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
- •Have donated blood of more than 450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 3 calendar months
- •Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy
研究组 & 干预措施
Placebo
Participants received placebo orally once daily (QD) for three consecutive days.
干预措施: Placebo (Drug)
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
干预措施: LY3493269 (Drug)
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
干预措施: Salcaprozate Sodium (Drug)
24 mg LY3493269 + 600 mg SNAC
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
干预措施: LY3493269 (Drug)
24 mg LY3493269 + 600 mg SNAC
Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
干预措施: Salcaprozate Sodium (Drug)
12 mg LY3493269 + 300 mg SNAC
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
干预措施: LY3493269 (Drug)
12 mg LY3493269 + 300 mg SNAC
Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
干预措施: Salcaprozate Sodium (Drug)
4 mg LY3493269 + 300 mg SNAC
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
干预措施: LY3493269 (Drug)
4 mg LY3493269 + 300 mg SNAC
Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
干预措施: Salcaprozate Sodium (Drug)
结局指标
主要结局
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
时间窗: Baseline through Day 44
TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269(Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose)
- PK: Maximum Concentration (Cmax) of LY3493269(Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose)