NCT02571140已完成1 期
A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Peak Plasma Concentration
研究概览
简要总结
This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation. The study is also designed to assess the reproducibility of pharmacokinetic profiles with various formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed Informed consent to the study.
- •Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive,
- •Subjects able to adhere to the visit schedule and protocol requirements
- •Hematology ,Chemistry and Urinalysis values with no clinical significance or do not reflect a medical condition which according to the physicians' judgment might confound the results of the study or pose additional risk to the subject by participation in the study.
- •Hemoglobin level > 12.5 g/dl
- •Blood pressure levels with no clinical significance.
- •Negative serology to HIV, Hepatitis B, Hepatitis C.
- •No known drug and alcohol abuse
- •Negative urinary drugs of abuse at screening
- •No sensitivity to dairy products
- •No allergy to soy bean products.
- •No prescription medications taken within one month to enrollment
- •Over-the-counter drugs (including vitamins) taken within 14 days prior to visit 2 are subject to the investigators' discretion for inclusion.
- •No subjects with previous urolithiasis.
- •Non-smoking In good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening
排除标准
- •Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- •Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
- •Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- •Active infections
- •History of drug or alcohol abuse
- •Known allergies or sensitivities to components of study treatment or study procedures, including Soy.
- •Clinically diagnosed psychiatric disorders that may interfere with patient study participation
- •Medical history known or suspected to increase risks of AEs related to study drug, up to the investigator's discretion
- •Chronic illnesses, up to the investigator's discretion
研究组 & 干预措施
Active Comparator
Active Comparator
Subcutaneous injection of Teriparatide
干预措施: Teriparatide (Drug)
Oral PTH (1-34)
Experimental
Oral administration of pill with API with different optimizations
干预措施: Oral PTH (1-34) (Drug)
结局指标
主要结局
Peak Plasma Concentration
时间窗: 60-522 days
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile
次要结局
- Adverse Events(60-522 days)
研究者
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