ACTRN12613000400763已完成1 期
A Phase I, Open-Label, Randomised, Single Dose, Crossover Pharmacokinetic Study Comparing a Capsule Formulation of BIT225 to the Current Oral Suspension Administered in Healthy Participants.
Biotron Limited0 个研究点目标入组 14 人开始时间: 2013年4月12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
- 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 49 Years（—）
- 性别
- All
入选标准
- •1. Be male or female (of non-child bearing potential), aged between 18 and 49 years (inclusive).
- •2. Healthy participants – defined as participants who are free from clinically significant illness or disease as determined by their medical history, physical examination, 12- lead ECG (QTc less than 450 ms) and clinical laboratory determinations.
- •3. Normotensive (systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg).
- •4. Body Mass Index (BMI) btween 19 and 29 kg/m2.
- •5. Weight between 55 kg and 110kg.
- •6. Participants who smoke less than one cigarette or tobacco form (including cigars) per month in the last 12 months.
- •7. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
- •8. Fluent in the English language.
- •9. Provide written informed consent to participate in the study and be willing to comply with the study procedures.
- •10. No abnormal finding of clinical relevance at the screening evaluation.
- •11. Agree to use a combination of two approved methods of contraception, from screening and until 30 days after administration of the study drug.
- •12. Females must have a negative pregnancy test at Screening (baseline) and Day -1.
排除标准
- •1. Currently taking or have taken antiretroviral therapy in the last 30 days.
- •2. Any condition that would interfere with drug absorption (e.g. chronic diarrhoea).
- •3. A history of pancreatitis or hepatitis within the previous 3 years.
- •4. Abnormal laboratory test results, deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee), within 21 days before enrolment, including anaemia (haemoglobin less than 11.0 g/dl for men and 10.0 g/dl for women), neutropenia, thrombocytopenia and elevated liver function test results more than two times the upper limit of normal. Renal function impairment (Creatinine clearance less than 50mL/min).
- •5. Unable to withhold concomitant medication for 48 hours prior to dosing and for the duration of confinement.
- •6. As a result of medical review, physical examination or screening investigations, the Medical Officer considers the participant unfit for the study.
- •7. Positive urine drug test or alcohol breath test at screening.
- •8. Use of macrolide antibiotics (eg. Erythromycin), azole antifungal agents (eg. Ketoconazole) within 30 days of study dosing.
- •9. Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder.
- •10. History of epilepsy.
- •11. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
- •12. Acute therapy for a serious infection within 30 days of study entry.
- •13. Positive screening test for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody and HIV.
- •14. Have participated in a clinical trial or receipt of an experimental therapy within 60 days prior to dosing.
- •15. Blood donation of greater than 550 mL within 90 days before the first dose administration.
- •16. Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.
- •17. Those who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling.
- •18. Unwilling or unable to fast for the 10 hours prior to dosing.
- •19. Women of child bearing potential, pregnant or breast feeding women.
- •20. Male partners of pregnant females.
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