ISRCTN54981564已完成1 期
A Phase I, blinded, randomized, single-centre, parallel-group, single-dose, dose-escalation, placebo-controlled study of the safety, tolerability, and pharmacokinetics of DNDI-6148 after oral dosing in healthy male 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
- Male
入选标准
- •1. Healthy Caucasian male volunteer aged 18 to 50 years inclusive
- •2. Non-smoker or light smoker of not more than 5 cigarettes a day. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study
- •3. Body Mass Index (BMI) between 18 and 30.1 kg/m2 inclusive at screening
- •4. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical and neurological examination)
- •5. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
- •5.1. 95 mmHg = Systolic Blood Pressure (SBP) = 140 mmHg
- •5.2. 50 mmHg = Diastolic Blood Pressure (DBP) = 90 mmHg
- •5.3. 45 bpm = HR = 90 bpm
- •5.4. Or considered NCS by investigators
- •6. Normal ECG recording on a 12-lead ECG at the screening visit:
- •6.1. 120 ms < PR < 210 ms
- •6.2. QRS < 120 ms
- •6.3. QTcf = 430 ms for male
- •6.4. No sign of any relevant trouble of sinusal automatism
- •6.5. Or considered as non-clinically significant by investigators
- •7. Laboratory parameters within the normal range of the laboratory (hematological, hormonology, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged non-clinically significant by the Investigator; for example, isolated elevated bilirubin is acceptable if judged by the physician without clinical relevance (i.e. Gilbert's syndrome)
- •8. ALAT, ASAT and Creatinine values strictly within the normal range
- •9. A negative result for diagnostic test of SARS-CoV-2 at D-1
- •10. Normal dietary habits
- •11. Provision of written informed consent to participate as shown by a signature on the volunteer consent form, after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate
- •12. Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study
- •13. Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research
- •14. Must agree to adhere to the contraception requirements defined in Section 4.3: use of condom by the male volunteer plus an effective method of contraception for the volunteer or their partner of childbearing potential from study drug administration until 90 days post-dosing OR use of a condom for 10 days post-dosing if the partner is known to be pregnant
排除标准
- •1. Having previously received DNDI-6148, or who participated in another clinical trial within 3 months prior and during the study, or 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial)
- •2. Any history (direct questioning) or presence (physical examination) of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious acute or chronic disease; including known or suspected HIV, HBV or HCV infection
- •3. With any clinically significant abnormality following review of pre-study laboratory tests, vital signs, full physical examination and ECG
- •4. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
- •5. Who have a history of allergy, intolerance or photosensitivity to any drug
- •6. Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug
- •7. Who have a history of additional risk factors for Torsades de Pointe” (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •8. Current suicide risk or history of suicide risk (CSSRS baseline: yes” answer to items 4 and/or 5); participants with a yes” answer for current suicide risk should be referred for psychiatric evaluation
- •9. Participants with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- •10. Who used a prescription medicine during the 28 days before the first dose of trial medication or use of an over-the-counter medicine (including antacid drug, with the exception of acetaminophen (paracetamol)), during the 7 days before the first dose of trial medication
- •11. History or presence of drug or alcohol abuse (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol)
- •12. Excessive consumption of beverages with xanthine bases (more than one liter/day)
- •13. Who drink more than 8 cups daily of beverage containing caffeine
- •14. Who has regular daily consumption of more than 5 cigarettes daily, or use more than 3 grams (1/8 ounce) of tobacco
- •15. Who use dietary supplements or herbal remedies (such as St John’s Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathways during the 28 days before the first dose of trial medication
- •16. Grapefruit should also be avoided during the 7 days before the first dose of trial medication
- •17. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV 1 or 2) tests
- •18. Positive results of screening for drugs of abuse (opiates, cocaine, amphetamine, cannabis, benzodiazepines)
- •19. Blood donation (including in the frame of a clinical trial) within 12 weeks before administration
- •20. General anaesthesia within 3 months before trial medication administration
- •21. Inability to abstain from intensive muscular effort
- •22. Who have any clinical condition or prior therapy which, in the opinion, of the Investigator, made the participant unsuitable for the study
- •23. Who had surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally
- •24. Who had febrile illness within 1 week before the start of the study
- •25. Participant who, in t
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