A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYDPLA1, a novel DPP- IV inhibitor, following oral administration in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.
研究概览
简要总结
This study will be a randomized, double-blind, placebo-controlled, multi-Centre trial. The objective of the study is to evaluate the safety, tolerability and pharmacokinetics of ZYDPLA1, a novel DPP- IV inhibitor, following oral administration in healthy volunteers.
According to the dosage schedules, the study has been divided in the following four plans-
Plan I: Single dose trial,
Plan II: Multiple dose trial,
Plan III: Gender effect trial,
Plan IV: Food effect trial.
An approximately 112 subjects shall be enrolled. At least one panel will be conducted in centre 2 (India) on selected dose from selected plan as per the study protocol.
The volunteers, who are found normal and healthy at the time of screening, satisfy inclusion and exclusion criteria and are willing to give the informed consent, will be invited to participate in the study.
Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality. Frequency of AEs with ZYDPLA1 will be compared with the placebo group. Further dose escalation will be stopped as per stopping criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female between 18 and 65 years of age.
- •Male subjects must agree to use one of the contraception methods during the study.
- •BMI within the range 18.0 – 30.0 kg/m2 BMI value should be rounded off to one significant digit after decimal point.
- •BMI values should be rounded to the nearest integer (ex.
- •30.4 rounds down to 30, while 17.5 rounds up to 18).
- •Capable of giving written informed consent, which includes compliance with protocol.
- •QTc interval < 450msec
- •For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited.
- •Negative Urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine within 28 days prior to initiation of the study and prior to check-in.
排除标准
- •Presence or history of pancreatitis at any time {Serum Amylase/ Serum Lipase more than significant upper normal limit (≥1.5X UNL)}.
- •Presence or history of severe gastrointestinal disease in the last 6 months
- •Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL) }
- •Active liver disease and/or liver transaminases greater than 1.5 X UNL
- •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)
- •History or presence of any medication in the last 14 days
- •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)
- •Intolerance to venipuncture
- •Systolic blood pressure more than 150 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg
- •Pulse rate less than 50/minute and more than 100/minute
- •Any clinically significant laboratory findings during screening as determined by the Principal Investigator
- •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 30 days.
- •(Subjected to insurance that subject has not participated in long acting drug including new biological entities/new chemical entities/biosimilar products)
- •Volunteers who have donated one unit (450 mL) of blood in the past 3 months
- •Positive Alcohol breath analyzer at the time of Screening and Checkin
- •A positive hepatitis screen (includes subtype B and C) and/or a positive test result for HIV antibody and/or syphilis (RPR).
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal investigator or Sub-investigator, could contraindicated the study participant’s participation in this study.
- •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 measures -History of less than 1 year of menopause and not using adequate long-term anti-fertility measures -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 -Positive serum β-hCG level at the screening visit.
结局指标
主要结局
Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.
时间窗: Clinical examination, vital signs like oral temperature, sitting blood pressure and pulse and laboratory tests will be done at screening | and at time points described as per protocol. | Continuous ECG monitoring and 12-lead ECG will be done as per time points described in the protocol. | Adverse event shall be monitored through out the study period.
次要结局
- 1. Pharmacokinetics (PK) after single and multiple oral dose(administrations in healthy male volunteers)