ISRCTN30122193已完成1 期
A Phase I, double-blind, randomised, single-centre, parallel-group, multiple-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
- 45
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 or healthy women of non-childbearing potential (WONCBP) between 18 and 55 years of age inclusive at the time of signing informed consent
- •2. Female subject of non-childbearing potential. WONCBP is defined as women who are postmenopausal or permanently sterilised (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- •3. Female post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a serum FSH result of =40 IU/L at Screening
- •4. Male subject (and subject’s partner of childbearing potential) must use condom and also willing to use a highly effective method of contraception or 2 effective methods of contraception (see Section 10.5.2), if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from first dose until 3 months after last dose of IMP
- •5. Body mass index (BMI) of 18.0 to 30.1 kg/m2 as measured at Screening and body weight =60 kg (BMI = body weight (kg) / [height (m)]2)
- •6. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP
- •7. Subject with a negative urinary drugs of abuse (DOA) screen (including alcohol and cotinine) test results, determined within 28 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator’s discretion)
- •8. Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening
- •9. General good physical health determined by medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory tests
- •10. 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
- •11. A resting heart rate (HR) between =50 and =100 bpm measured after 10 min rest in supine position at Screening, admission and pre-dose
- •12. ECG recording without clinically significant abnormality, including QTcF measure of =450 msec at Screening, admission and pre-dose
- •13. No febrile seizures or infectious illness for at least 7 days prior to first administration of the IMP (Day 1)
- •14. Must agree to adhere to the contraception requirements and the life-style restrictions
- •15. Subject must be available to complete the study (including all follow-up visits)
- •16. Subject must satisfy an Investigator about his/her fitness to participate in the study
- •17. Subject must provide written informed consent to participate in the study
排除标准
- •1. Subjects who have received any IMP in a clinical research study within 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 urine alcohol test at Screening or admission
- •7. Current smokers or those who have smoked within the last 12 months with a positive cotinine result at Screening and Admission
- •8. Current users of cigarette replacements (i.e. e-cigarettes, nicotine patches or gums) and those who have used these products within the last 12 months
- •9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at Screening
- •10. Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the Investigator or AST/ALT/total bilirubin/gamma-glutamyl transpeptidase [GGT]/ALP/creatinine >1.2 ULN. Subjects with Gilbert’s syndrome are allowed
- •11. Positive PCR COVID-19 test at admission
- •12. Evidence of renal impairment at Screening or admission, as indicated by an estimated Glomerular Filtration Rate (GFR) 13. History of clinically significant cardiovascular, renal, hepatic, neurological (especially seizures), immunological, psychiatric, myopathies, bleeding tendency, respiratory and particularly gastrointestinal (GI) disease, especially peptic ulceration and chronic gastritis, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome, as judged by the Investigator
- •14. History of additional risk factors for Torsades des Pointe (i.e. heart failure, hypokalaemia, family history of long QT syndrome)
- •15. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency
- •16. Any relevant GI complaints within 7 days of dosing
- •17. 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)
- •18. Presence or history of clinically significant allergy requiring treatment (including asthma, urticaria, clinically significant allergic rash or other severe allergic diathesis), as judged by the Investigator. Hay fever is allowed unless it is active
- •19. Donation or loss of greater than 500 ml of blood within the previous 3 months or more than 100 ml within 30 days prior to signature of informed consent
- •20. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (including anti-acid drugs) or vitamins/herbal remedies (i.e. St. John’s Wort and others which are known to interfere with the CY
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