ACTRN12610000721000已完成1 期
A Phase 1, Single-Center, Dose-Escalation and Fixed-Dose Crossover, Cohort Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of PF329 versus oral hydromorphone hydrochloride (HCl) in Healthy Subjects
PharmacoFore, Inc.0 个研究点目标入组 80 人开始时间: 2010年8月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
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, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and Human Immunodeficiency Virus (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, Intra-Uterine Device (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 12-lead Electrocardiogram (ECG), and normal vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure between 100-140/60-90 mmHg, heart rate between 48-99 beats per minute, temperature between 35.8 degrees Celsius and 37.8 degrees Celsius), and Oxygen Saturation measured by pulse oximetry (SpO2) > 96 percent 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
排除标准
- •1.History of allergy or sensitivity to hydromorphoneor sulfites
- •2.History of loud snoring or sleep apnea
- •3.History of medical problems encountered with opioid therapy
- •4.Urinary cotinine levels indicative of smoking or history of regular use of tobacco-containing or nicotine-containing products within 2 months prior to screening
- •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 opioid 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
研究者
相似试验
已完成
不适用
Investigating a new Vaccine Against Meningitis B (in Oxford)Meningitis BInfections and InfestationsNeisseria meningitidis serotype BISRCTN46336916niversity of Oxford88
招募中
不适用
A Phase I/IIa (dose-escalation, single-center, open-label, Phase I and randomized, observer-blind, multi-center, placebo-controlled, Phase IIa) study to determine safety, tolerance and immunogenicity of a preventive COVID-19 vaccine ‘mRNA SARS-CoV-2 Vaccine (EG-COVID)’ in healthy adultKCT0006670Eyegene45
进行中（未招募）
1 期
A Phase I clinical trial to evaluate the safety and the activity of the oncolytic adenovirus VCN-01 in patients with refractory retinoblastomaEUCTR2016-001060-11-ESFundació Sant Joan de Déu
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 SubjectsACTRN12612000880842Signature Therapeutics, Inc.14
进行中（未招募）
不适用
A phase I dose escalation, multi-center, open-label study of AUY922 administered IV on a once-weekly schedule in adult patients with advanced solid malignancies including phase II expansion arms in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. - N/ADose-expansion study to assess safety, tolerability & efficacy:-One arm (MTD expansion) will enroll advanced cancer patients (other than breast carcinoma).-Two arms (phase II) to assess response in following breast cancer patients:1. HER2+ inoperable locally advanced or metastatic breast cancer.2. ER+ inoperable advanced/metastatic breast cancer progressed on at least 1 and received up to 3 lines of standard seq. endocrine therapy and who received up to 2 lines of cytotoxic therapy.EUCTR2006-002766-20-GBovartis Pharma Services AG