Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
研究概览
简要总结
This study has four parts. Each participant will enroll in one part.
Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.
Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.
Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.
Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.
This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.
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)
盲法说明
Part A, B and D are not blinded. Part C is blinded to Participant and Investigator
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females, as determined by medical history and physical examination
- •Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product
- •Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state
- •Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive
排除标准
- •Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening
- •Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any 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
- •Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data
研究组 & 干预措施
5 mg Tirzepatide SC (Solution)-Part A
Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation.
干预措施: Tirzepatide (Drug)
5 mg Tirzepatide SC (Lyophilized)-Part A
Participants received 5 mg of tirzepatide SC lyophilized formulation.
干预措施: Tirzepatide (Drug)
0.5 mg LY3298176 IV-Part B
Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation.
干预措施: Tirzepatide (Drug)
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
Participants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
干预措施: Tirzepatide (Drug)
Placebo SC-Part C
Participants received SC injection of placebo.
干预措施: Placebo (Drug)
0.5 mg LY3298176 Bolus IV-Part D
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
时间窗: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose
PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
时间窗: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
时间窗: Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose
PK Part B: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
次要结局
- PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide(Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose)
- PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide(Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose)
- PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide(Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose)