ACTRN12614001326684已完成1 期
Single Ascending Dose and Multiple Ascending DosePhase 1 Study to determine the safety, tolerability, pharmacokinetic and pharmacodynamic parameters of PXS-4728A Administered Orally inHealthy Adult Males
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •healthy males.
- •- BMI - 18.5 to 30 kg/m2.
- •- no clinically relevant abnormality in an ECG; QTcF (QTc Fredericia’s correction) less than or equal to 450 ms, PR interval of 120-210 ms and a QRS duration less than or equal to 120 ms.
- •- adequate venous access.
- •- agree to use two approved methods of contraception from screening and until 30 days after administration of the study drug.
- •- has given written informed consent.
排除标准
- •- clinically significant abnormal findings on the physical examination or medical history.
- •- clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin or cardiovascular disease.
- •- history of significant drug allergies/ allergic reaction or currently suffers from clinically significant systemic allergic disease.
- •- abnormal wound healing as the result of surgery or trauma.
- •- received or is anticipated to receive any prescription systemic or topical medication within 14 days prior to the start of dosing or within 5 half lives of the drug, whichever is greater, or use any complimentary or alternative medicine 48 hours prior to the start of dosing or within 5 half
- •lives of the drug whichever is greater (excluding paracetamol).
- •- systolic blood pressure <100 or >140 mmHg, diastolic blood pressure <50 or >90 mmHg and heart rate (HR) <55 or >95 bpm.
- •- ALT, AST or bilirubin >2x ULN.
- •- significant renal insufficiency, with an estimated
- •creatinine clearance less than 60 mL/min at screening.
- •- positive screening test for HbsAg or Hep C.
- •- history of drug abuse in the last 2 years.
- •- drink more than three (3) units of alcohol daily
- •- used nicotine-containing products within 6 weeks before screening and unable to abstain until study completion.
- •- consumed caffeine and/or xanthine products for at least 48 hours prior to admission to the clinical facility, and whilst confined to the clinical facility.
- •- consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, red wine or other alcohol within 7 days prior to administration of study drug.
- •- positive urine screen for drugs of abuse and alcohol breath test at screening and study check-in.
- •- receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.
- •- clinically significant abnormality detected on telemetry pre-dose.
- •- systemic infection other than coryza in the last week prior to dosing
研究者
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