ACTRN12612000880842已完成1 期
A Phase 1, Single-Center, Dose-Ranging, Multi-Treatment Study to Determine the Safety and Pharmacokinetics of Single Oral Dose Combinations of PF329 and Nafamostat Mesilate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1.Males or females, ages 18-50 years in good general health
- •2.Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive)
- •3.Subjects must have a negative screen for drugs of abuse, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.
- •4.Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at randomization.
- •5.Female subjects must use a medically acceptable method of birth control (oral or transdermal contraceptives, condom, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner) from the time of screening through two weeks after the last study treatment.
- •6.Subjects must have normal findings in a physical examination and a 12-lead ECG, and normal vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure (sitting) between 100-140/60-90 mmHg, heart rate (sitting) between 48-99 beats per minute, temperature between 35.8 degrees C and 37.8 degrees C) as well as SpO2 > 96% in the absence of supplemental oxygen.
- •7.Clinical laboratory values must be within the normal limits as defined by the clinical laboratory, unless the Investigator decides that out-of-range values are not clinically significant.
- •8.Subjects must be able to provide meaningful written informed consent
- •9.Subjects must be willing and able to follow study instructions and be likely to complete all study requirements, which include participation in up to 7 study treatment sessions
排除标准
- •1.History of allergy or sensitivity to hydromorphone or nafamostat
- •2.History of blood clotting disorders
- •3.History of loud snoring or sleep apnea
- •4.History of medical problems encountered with opioid therapy other than nausea and/or vomiting
- •5.History of alcoholism or drug abuse (prescription or illicit drugs)
- •6.Use of prescription or over-the-counter medications within 14 days of study drug administration except for contraceptive medications used by female subjects
- •7.Use of any opiate within 30 days prior to screening
- •8.Donation of blood within 30 days prior to screening
- •9.Donation of plasma or participation in a plasmapheresis program within 7 days prior to screening
- •10.Acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection, or known inflammatory process) at admission to the clinical study unit
- •11.History of gastrointestinal disturbance requiring frequent use of antacid
- •12.Anticipated need for surgery or hospitalization during the study
- •13.Enrollment in an investigational drug study within 30 days prior to screening
- •14.Any condition, that in the Investigator’s opinion, (i) puts the subject at significant risk, (ii) could confound the study results or (iii) may interfere significantly with the subject’s participation in the study
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