ACTRN12624000718549已完成1 期
A Phase 1, Three-Part Open-Label Drug-Drug Interaction Study in Healthy participants to Determine the Effects of Itraconazole on the Pharmacokinetics of JNT-517 (Victim) and the Effects of JNT-517 (Perpetrator) on the Pharmacokinetics of Midazolam and Pravastatin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Males and females 18 to 55 years of age, inclusive.
- •2. Medically healthy with no clinically significant medical history, physical examination, laboratory results, vital signs, or ECGs.
- •3. Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs).
- •4. Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
- •5. Participants with psychiatric illness must be well-controlled for the last 6 months prior to the Screening visit and if on medication, on stable medications for the last 3 months.
- •6. Capable of giving signed informed consent and able to comply with study procedures
排除标准
- •1. Any acute or chronic medical condition that would prevent the participant from complying with
- •the procedures or place the participant at risk if they participate in the study.
- •2. Positive for hepatitis B or C or human immunodeficiency virus.
- •3. Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
- •4. Any history of liver disease
- •Any surgical or medical conditions that may affect study drug absorption, distribution,
- •metabolism, or excretion.
- •6. Creatinine clearance <90 mL/min by the Chronic Kidney Disease Epidemiology Collaboration
- •(CKD-EPI) creatine equation.
- •7. Received another investigational drug within 30 days or, if known, 5 half-lives of the
- •investigational drug (whichever is longer).
- •8. Alcohol consumption within 5 days of Check in and/or unwilling to abstain during the study.
- •9. Has consumed herbal preparations/medications, including but not limited to St. John's wort, kava,
- •ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, or ginseng,
- •within 7 days prior to study drug dosing.
- •10. Intake of nutritional supplements, juice, other foods or beverages that may affect the various drug
- •metabolizing enzymes and transporters (eg, alcohol, grapefruit, starfruit, Seville oranges, or their
- •products) are not permitted for 7 days before dosing and throughout the study.
- •11. Smoker (defined as an individual who has used nicotine-containing products, including cigarettes
- •and e-cigarettes) within the last 2 weeks prior to dosing and a positive cotinine test on Day –1.
- •12. Consumption of caffeinated beverages or food within 72 hours prior to Check-in.
- •13. Use or intend to use any prescription medications/products within 14 days prior to dosing, unless
- •deemed acceptable by the Investigator (or designee), or use or intend to use any nonprescription
- •medications/products including vitamins and minerals within 7 days prior to Check in, unless
- •deemed acceptable by the Investigator (or designee).
- •14. Use or intend to use slow release medications/products considered to still be active within 14
- •days prior to Check in, unless deemed acceptable by the Investigator (or designee).
- •15. Use of any medications that are inhibitors or inducers of cytochrome P450 (CYP)3A4 or
- •inhibitors of the transporter P-glycoprotein (P-gp) within 4 weeks prior to randomization and
- •unwilling and/or unable to avoid these medications throughout the treatment duration.
- •16. Use of any medication that is a substrate of CYP3A4, or a substrate of the transporters P-gp,
- •breast cancer resistance protein (BCRP), organic anion transporter 3 (OAT3), multidrug and toxin
- •extrusion (MATE)1, or MATE2-K within 4 weeks prior to randomization and unwilling and/or
- •unable to avoid these medications throughout the treatment duration.
- •17. History of drug/alcohol abuse in the last year.
- •18. Positive drug screen.
- •19. Unable to tolerate oral medication.
- •20. Allergy to JNT-517 or any component of the investigational product.
- •21. Allergy to itraconazole (Part A), midazolam (Part B), or pravastatin (Part C)
- •22. Previous exposure to JNT-517 in another clinical trial
- •23. Received >50 mL of blood or plasma within 30 days of Screening or >500 mL of blood or plasma
- •within 60 days of Screening.
- •24. Blood donation of >500 mL within 56 days prior to Screening
研究者
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