ACTRN12622001271796已完成1 期
A phase 1, first-in-human study to asses the pharmacokinetics of single oral doses of JNT-517 in the fasted and fed states and to evaluate the comparative bioavailability of 2 formulations of JNT-517 in healthy participants.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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 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 at Screening and Day 1.
- •3. Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg.
- •4. Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
- •5. Females of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use two highly effective contraceptive methods from Screening until at least 1 week after the last study drug administration.
- •a. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test by Day 1.
- •6. Females not of childbearing potential or postmenopausal defined as follows:
- •a. Have had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
- •b. Have had amenorrhea for minimum of 1 year with confirmation by levels of follicle stimulating hormone testing
- •7. For male participants involved in any sexual intercourse that could lead to pregnancy, participant must agree to use highly effective contraceptive methods from Day 1 until at least 12 weeks after the last study drug administration.
- •Note: No restrictions are required for males who have undergone a documented vasectomy at least 4 months prior to Screening. If vasectomy procedure is not documented or was performed less than 4 months prior to Screening, males must follow the same contraception as for non-vasectomized participants.
- •8. Participants with psychiatric illness must be well-controlled for last 6 months prior to the Screening visit and if on medication, on stable medications for the last 3 months.
- •9. Capable of giving signed informed consent and ability 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.
- •5. Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
- •6. Creatinine clearance <90 mL/min by Cockcroft-Gault formula.
- •7. Participation in another investigational drug trial within 30 days or, if known, 5 half-lives of the investigational drug (whichever is longer).
- •8. Alcohol consumption within 5 days of randomization and/or unwilling to abstain during the study.
- •9. 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.
- •10. 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.
- •11. History of drug/alcohol abuse in the last year.
- •12. Inability to tolerate oral medication.
- •13. Allergy to JNT-517 or any component of the investigational product.
- •14. Given >50 mL of blood or plasma within 30 days of Screening or >500 mL of blood or plasma within 60 days of Screening.
- •15. Any of the following laboratory values at the Screening visit:
- •Alanine aminotransferase or aspartate aminotransferase values >upper limit of normal (ULN)
- •Total bilirubin >ULN
- •Haemoglobin <11.0 g/dL (<110.0 g/L)
- •White blood cell count <4.5 × 10 9/L (<4500/mm3)
- •Platelet count <150 × 10 9/L (<150,000/mm3)
- •16. Smoker (defined as an individual who has used nicotine-containing products, including cigarettes and e-cigarettes) within the last 2 weeks prior to dosing.
- •17. Positive for cotinine or drug screen.
研究者
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