A safety, pharmacokinetics and pharmacodynamics study of CPL-2009-0031 in healthy volunteers and patients with Type 2 Diabetes mellitus (T2DM).
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Stage I : To evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses, by observing:
研究概览
简要总结
Present study is safety, pharmacokinetic and pharmacodynamic study of CPL-2009-0031. Stage I of study will be conducted in healthy volunteers.
The primary objectives for stage-I of the present study is to evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses.
In Stage I, 12 subjects will be randomized in 3:1 randomization ratio (CPL-2009-0031 against its matching placebo, respectively) for each of following cohort:
Cohort (Dose-level) -I: CPL-2009-0031 (35mg) and its matching placebo
Cohort (Dose-level) –II: CPL-2009-0031 (70mg) and its matching placebo
Cohort (Dose-level) –III: CPL-2009-0031 (140mg) and its matching placebo
After an overnight fasting of at least 10 hours, subjects will be administered study drugs with 240 ml of water. Subjects will remain in the study center for a period of 24 hours post-dosing to monitor safety aspects and to collect blood samples for pharmacokinetic analysis. The study duration for subject will be 7 days post-dosing. Adverse events will be monitored throughout the study (days- 0 to 7) by investigator inquiries and spontaneous reports. They will be recorded in terms of symptoms and signs, duration, severity, relationship with the study drug, action taken, and seriousness. In addition, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and oral temperature), 12-lead ECGs, and clinical laboratory tests will be used to determine adverse events and clinically significant laboratory values.
The physical examination and vital sign measurements will be performed at pre-dose and at 2.0, 4.0, 6.0, 12.0, 24.0, 48.0, 72.0 and 168.0 h post-dose. 12-lead ECG will be performed at 2.0, 4.0, 12.0, 24.0, 48.0, 72.0 and 168.0 h post-dose. Hematology, blood biochemistry and urine R/M analysis will be performed at 168.0 h post-dose as a part of post-dose laboratory safety assessments. Blood glucose will be monitored by appropriate and validated glucometer at 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0 h post-dosing. Apart from these time-points, investigator may call for the safety assessments at any time, as and when required.
4 ml of blood sampling for the analysis of plasma CPL-2009-0031 and sitagliptin will be performed within 1 hour prior to dosing (0.0 h) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, 72.0 h post-dose from an indwelling cannula inserted in a forearm vein into an EDTA-2K-containing tube. Intravenous indwelling cannula will be kept in situ as long as possible by injecting,
The plasma CPL-2009-0031 and sitagliptin will be quantified using LC-MS/MS method.
For laboratory investigations at screening (15.0 ml) and post-study safety evaluations (5 ml), blood will be collected in EDTA vacutainers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Stage I Subject willing to comply with the protocol and has signed ethics committee approved informed consent form (ICF).
- •ï‚§Healthy adult male within age group of 18-55 years BMI in the range of 18.5 – 24.9 kg/m2 No hypersensitivity or contraindication to DPP-IV inhibitors or excipients of investigational drug formulation Free of any acute/chronic illness Subjects who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
- •ï‚§Documented negative test for human immuno virus (HIV-1/2), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
- •ï‚§Sexually active male subject with partners of childbearing potential must practice acceptable barrier contraception during the treatment and at least 2 months after the last dose to prevent his partner from becoming pregnant during the study.
排除标准
- •ï‚§History or currently consuming drugs of abuse or alcohol.
- •ï‚§Subjects who has received any drug other than OTC product within 30 days of dosing or any OTC product 7 days prior to dosing Participation in another clinical trial in the past 3 months.
- •ï‚§Subject with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor.
- •ï‚§Subjects with history of smoking or currently having smoking habit will not be included in the study.
- •ï‚§History of hypotensive episodes, or systolic blood pressure reading of <100 mm Hg or a diastolic reading of <60 mm Hg at time or history of hypertension, or systolic blood pressure reading of >139 mm Hg or a diastolic reading >89 mm Hg at time of general physical examination.
- •ï‚§Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of each period or alcoholic products consumption within 48 hours prior to the dosing of each period.
- •ï‚§ Subjects otherwise judged by the investigators or sub-investigator to be inappropriate for inclusion in the study.
结局指标
主要结局
Stage I : To evaluate safety and tolerability of CPL-2009-0031 at its single-escalating doses, by observing:
时间窗: Safety will be observed till 7 days post-dose.
1. Frequency of Serious adverse events
时间窗: Safety will be observed till 7 days post-dose.
2. Number and severity of hypoglycemic events
时间窗: Safety will be observed till 7 days post-dose.
次要结局
- Stage I: To determine safety, tolerability and pharmacokinetics of CPL-2009-0031 at its single-escalating dose.(Frequency and severity of adverse events)