CTRI/2012/05/002691Other1 期
A phase I, randomized, double-blind, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435 in healthy, overweight and/or obese subjects
Piramal Healthcare Limited0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Willingness and are able to provide a written informed consent to participate in the study.
- •2.Healthy adult male subjects aged between 18 and 45 (both inclusive) years old (Parts A and B). Healthy adult male subjects aged between 18 and 60 (both inclusive) years old (Part C).
- •3.BMI between 19 and 23 kg/m2 (Parts A and C only). Overweight (BMI between 23 and 25 kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in Part B only.
- •4.Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiograms (ECG).
- •5.Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
- •6.Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, â??power drinksâ??) and grapefruit juice from 72 hrs prior to each admission until discharge and throughout the study.
- •7.Have a high probability for compliance with the study procedures including ability and willingness to swallow capsules during the study and ease of withdrawing blood samples.
- •8.All values of hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the investigator and discussed with the sponsor a priori
排除标准
- •1.Employees of the Sponsor and CRO or clinical sites.
- •2.Female subjects
- •3.No past or current serious diseases of any organ will be allowed. Exceptions may be non-malignant skin diseases, childhood asthma and other conditions as per the investigatorâ??s discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
- •4.History of sleep apnea, history of irregular sleep/wake cycle or working in night shifts.
- •5.Acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days before Day -2 of the study.
- •6.History of hypo or hyperthyroidism or repeated abnormal TSH values at screening, obesity of endocrine origin.
- •7.History of anaphylaxis or angioedema, bronchial asthma, peptic ulcer and clinically important food or drug allergy.
- •8.History of mental handicap, psychiatric disorders including eating disorders, seizures or significant head trauma.
- •9.History of drug abuse, addiction or use of recreational drug.
- •10.History of alcoholism for more than 2 years or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol â?? one glass wine, half pint beer, one measure or ounce of spirit).
- •11.History of fainting from blood collections or vasovagal syncope.
- •12.Previous exposure to P7435 or participation in any of the previous cohorts.
- •13.Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- •14.Positive findings in urine drug screen.
- •15.Positive finding in alcohol breath test.
- •16.Participation in another clinical trial within 90 days of the first drug administration.
- •17.Use of any prescription drugs including sedatives and steroids within 30 days before first drug administration. Use of any over-the-counter drugs including herbal supplements, health supplements, and others such as St. Johnâ??s Wort extract and other drugs causing pharmacokinetic interactions within 14 days before the first drug administration. Weight loss medications (including alternate medicine products) within 90 days before the first drug administration.
- •18.Intake of unusual diet e.g. low caloric, low sodium, for 30 days before first drug administration.
- •19.Intake of more than 8-10 cups of coffee and/or tea per day and consumption of methyl xanthine-containing beverages (tea, coffee, cola drinks, chocolate) within 48 hours prior to Day -1 of each study.
- •20.Donation of blood (i.e. 350 ml) within 90 days before Day â??1 of the first treatment period.
研究者
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