NCT01764425终止1 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
详细描述
- A phase I, randomized, double-blind, placebo-controlled, dose escalating study of P7435 to determine the safety, tolerability, pharmacokinetics, food effect and pharmacodynamics of single and multiple ascending doses of P7435.
- Subjects participating will be either healthy subjects or healthy overweight and/or obese subjects. In this study, overweight/obese are defined as subjects having a BMI of 23 kg/m2 and above.
- The study will be conducted in 3 parts as follows: Part A will consist of the Single Ascending Dose (SAD) study, Part B will consist of the Multiple Ascending Dose (MAD) study and Part C will consist of the Food Effect study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willingness and are able to provide a written informed consent to participate in the study.
- •Healthy adult male subjects aged between 18 and 45 (both inclusive) years old
- •BMI between 19 and 23 kg/m
- •Overweight (BMI between 23 and 25kg/m2) and/or obese (BMI between 25 and 35 kg/m2) but otherwise healthy subjects in PartB .
- •Healthy as determined by the investigator
- •Smoking less than 10 cigarettes per day and able to refrain from smoking during confinement.
- •Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, "power drinks") and grapefruit juice to admission.
排除标准
- •Employees of the sponsor or clinical sites.
- •Female subjects.
- •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 Investigator's discretion and discussed with the Sponsor a priori. History of significant gastrointestinal disease or other significant diseases including cardiac, renal or liver impairment.
- •History of sleep apnea, irregular sleep/wake cycle or working in night shifts.
- •Acute disease state
- •History of hypo/hyperthyroidism or repeated abnormal TSH values at screening or obesity of endocrine origin.
- •History of alcoholism for more than 2 years
- •Positive serology for human immunodeficiency virus (HIV-1/2) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- •Positive findings in urine drug screen / alcohol breath test.
- •Participation in another clinical trial within 90 days of the first drug administration.
- •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 study.
- •Donation of blood (i.e. 350 ml) within 90 days before Day -1 of the first treatment period.
研究组 & 干预措施
P7435
Active Comparator
Tablets for once daily oral administration, For SAD part of the study dose would be 10 mg for Cohort 1; Cohorts 2, 3, 4 and 5 will be dosed subsequently at 30 mg, 100 mg, 300 mg, 1000 mg respectively Dose for MAD and food effects part of the study would be based on SAD study results
干预措施: P7435 (Drug)
Placebo
Placebo Comparator
Placebo tablets for oral administration
干预措施: P7435 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to Day 5
- Number of participants with adverse events in the single and multiple ascending dose studies.
Effect of food on drug concentrations
时间窗: Day 1
次要结局
- Pharmacokinetics profile (Cmax, Tmax, and AUC)(Day 1 and Day 14)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187OverweightDiabetes Mellitus Type 2 in ObeseNCT01874366Piramal Enterprises Limited96
已完成
1 期
Single Dose Study of SHR4640 in Healthy SubjectsHyperuricemia GoutNCT02815839Jiangsu HengRui Medicine Co., Ltd.50
已完成
1 期
SAD Study of IA-14069HealthyNCT05317741ILAb Co., Ltd.40
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese SubjectsHealthy VolunteerNCT02176252Ardelyx83
已完成
1 期
ANG-3070 in Healthy Adult ParticipantsHealthy VolunteersNCT04196179Angion Biomedica Corp97