ISRCTN14683791已完成1 期
A phase I, double-blind, randomised, single centre, parallel group, single-dose, dose-escalation, placebo-controlled study of the safety, tolerability and pharmacokinetics of DNDI-0690 after oral dosing in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy males (Cohorts 1 to 7) or healthy WONCBP (Cohort 8)
- •2. 18 to 55 years (Cohorts 1 to 7) or 18 to 60 years (Cohort 8) of age at the time of signing informed consent
- •3. Body mass index (BMI) of 18.0 to 30.1 kg/m² as measured at screening
- •4. General good physical health determined by medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory tests
- •5. Normal blood pressure: Systolic blood pressure between =90 and =140 mmHg, Diastolic blood pressure =90 mmHg, measured after 10 min rest in supine position at screening, admission and pre-dose
- •6. A resting HR between =40 and =90 bpm measured after 10 min rest in supine position at screening, admission and pre-dose
- •7. ECG recording without clinically significant abnormality, including QTcF measure of =450 msec (male) or =470 msec (female) at screening, admission and pre-dose
- •8. Having had no febrile seizures or infectious illness for at least 7 days prior to administration of the IMP (Day 1)
- •9. Must be willing and able to communicate and participate in the whole study
- •10. Must provide written informed consent
- •11. Must agree to adhere to the contraception requirements
排除标准
- •1. Subjects who have received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1
- •2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •3. Subjects who have previously been enrolled in this study and/or have received DNDI 0690 previously
- •4. History of any drug or alcohol abuse in the past 2 years
- •5. Demonstrating excess in caffeine/xanthine consumption (more than 6 cups of coffee or equivalent a day)
- •6. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type). As confirmed by a positive alcohol breath test at screening or admission
- •7. Current smokers and those who have smoked within the last 12 months. As confirmed by a breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation, bilateral tubal occlusion and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration =40 IU/L)
- •10. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •11. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis (especially AST, ALT, gamma glutamyl transpeptidase [GGT], ALP, creatinine, and BUN) as judged by the investigator (laboratory parameters are listed in Appendix 1). Subjects with Gilbert’s syndrome are allowed
- •12. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
- •13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •14. Evidence of renal impairment at screening or admission, as indicated by an estimated CLcr of <80 mL/min using the Cockcroft-Gault equation
- •15. History of clinically significant cardiovascular, renal, hepatic, neurological (especially seizures), immunological, psychiatric, myopathies, bleeding tendency, respiratory and particularly GI disease, especially peptic ulceration and chronic gastritis, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome, as judged by the investigator
- •16. History of additional risk factors for Torsades des Pointe (eg heart failure, hypokalaemia, family history of long QT syndrome)
- •17. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency
- •18. Any relevant GI complaints within 7 days of dosing
- •19. Subjects with a history of cholecystectomy or gall stones (Cohort 7 only)
- •20. Serious adverse reaction or clinically relevant hypersensitivity to any drug or the formulation excipients (Hypromellose [HPMC], sodium lauryl sulphate [SLS], sucrose, croscarmellose sodium and magnesium stearate)
- •21. Presence or history of clinically significant allergy requiring treatment (including asthma, urticaria,
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