A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers (ZYD1)
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, a Selective Glucagon-like Peptide (GLP) 1 Agonist, Following Subcutaneous Administration in Healthy Volunteers.
ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).
ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Gujarat
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Ahmedabad、Gujarat、印度、382213
- Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village : Moraiya,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: 18-45 years
- Mentally, physically, and legally eligible to give informed consent
- Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively
- Ability to communicate effectively with the study personnel
- Willingness to adhere to the protocol requirements
- For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.
Exclusion Criteria:
- Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation
- Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
- Presence or history of severe gastrointestinal disease in the last 6 months
- Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)
- Active liver disease and/or liver transaminases greater than 1.5 X UNL
- Subject with personal or family history of medullary thyroid cancer
- Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
- Subject with serum calcitonin >50 ng/L
- History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
- Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in
- History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
- History or presence of significant alcoholism or drug abuse within the past 1 year
- History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
- Difficulty with donating blood
- Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
- Pulse rate less than 60/minute and more than 100/minute
- Any clinically significant abnormal X-ray or laboratory findings during screening
- History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
- Major illness and/or major surgery in last 3 months
- Volunteers who have participated in any drug research study other than the present trial within past 3 months
- Volunteers who have donated one unit (350 ml) of blood in the past 3 months
For gender effect study, female volunteers with following criteria will not be recruited:
- History of pregnancy or lactation in the past 3 months
- Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility device or history of less than 1 year of menopause
- Using hormonal contraceptives
- Using hormone replacement therapy
- Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
- Positive urine pregnancy test on the day of check-in
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ZYD1
Tablet ZYD1 5 to 50 mg subcutaneously Once a day (OD) or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
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Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting. Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting. Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
其他名称:
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安慰剂比较:Placebo
Tablet Placebo 5 to 50 mg subcutaneously OD or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study)
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Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting. Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting. Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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To evaluate Safety and tolerability of ZYD1
大体时间:21 days
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The safety and tolerability shall be evaluated using physical examinations, standard laboratory tests (hematology, biochemistry and urine examination), and electrocardiogram (ECG).
Spontaneously reported and solicited adverse events will also be used for safety parameters.
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21 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Pharmacokinetics (PK) and Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers Gender effect study.
大体时间:1. For Plan I and III - Pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Plan II - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3,
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PK parameters evaluated for Plan I and Plan III: Cmax, Tmax, Area Under Curve (AUC)0-t, AUC 0-inf, T1/2, z, Clearance(CL), Volume of distribution (Vd) Plan II: Cmin, Tmin, Cavg, % Fluctuation, Accumulation Index, Clss, Cmax, Vd or Vss For urine data (Plans I, II, and III): Amount recovered, % recovered The following PD parameters (Plan I-III) will be evaluated: Plasma glucose, Serum insulin, C-Peptide, Glucagon Gender effects: PK and PD effect in female volunteers at preselected single dose will be compared with the results of single-dose study in male volunteers. |
1. For Plan I and III - Pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Plan II - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3,
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合作者和调查者
调查人员
- 研究主任:Rajendrakumar H Jani, PhD(Medical)、Senior Vice President - Cadila Healthcare Limited
- 首席研究员:Kevinkumar Kansagra, MD、Zydus Research Centre
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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