ACTRN12614000102673已完成1 期
A Phase 1, Double Blind, Randomized, Placebo Controlled, Parallel Design Pharmacokinetic Drug Interaction Study of ACH-0143102 and ACH-0142684 in Healthy Volunteers.
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy, adult, male or female subjects, 18 to 55 years of age, inclusive.
- •2. Continuous non smokers who have not used nicotine containing products for at least 3 months prior to the first dose.
- •3. Weigh at least 50kg and have a Body Mass Index (BMI) in the range 18 to 30.
- •4. Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs; as assessed by the PI.
- •5. Liver function tests (serum alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase [ALP]) and serum bilirubin (total and direct) must be below or equal to the upper limit of normal (ULN) at screening.
- •6. Females must be of non childbearing potential, defined as having undergone one of the following sterilization procedures at least 6 months prior to Day 1:
- •hysterectomy;
- •bilateral oophorectomy
- •bilateral tubal ligation or fallopian tube inserts or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 and have follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- •7. Males must use a condom with spermicide when engaged in sexual activity from first check in through 90 days beyond the last dose.
- •8. Males must agree to refrain from sperm donation from first check in through 90 days beyond the last dose.
- •9. Give voluntary written informed consent to participate in the study.
- •10. Able to effectively communicate with the Investigator and other center personnel, and willing to comply with all study requirements and restrictions.
排除标准
- •1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the PI.
- •2. History or presence of alcoholism and/or drug abuse within the past 2 years.
- •3. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •4. History or presence of diabetes mellitus or hyperglycemia, in the opinion of the PI.
- •5. Female subjects who are pregnant or lactating.
- •6. Have positive results for the urine drug screen at screening or check in.
- •7. Have positive urine cotinine at screening.
- •8. Have positive results at screening for HIV, HBsAg or HCV.
- •9. Seated sustained blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- •10. Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- •11. 12 lead ECGs which have clinically significant findings as judged by the PI or the PI’s designee at screening and prior to dosing, including:
- •QTcB interval is >450 msec;
- •PR interval > 200 msec.
- •QRS interval > 120 msec.
- •12. Has an estimated creatinine clearance < 90 mL/min based on the Cockcroft Gault equation at the screening visit.
- •13. Have used any drugs or substances known to be significant inhibitors of CYP enzymes and/or significant inhibitors or substrates of P gp and/or OATP within 14 days prior to the assigned first dose of study drug.
- •14. Have used any drugs or substances known to be significant inducers of CYP enzymes and/or P gp within 28 days prior to the assigned first dose of study drug.
- •15. Have been on a special diet within the previous 28 days which, in the opinion of the investigator, would interfere with subject safety or compliance with the protocol.
- •16. Have a hemoglobin level below the lower limit of normal at screening and first check in.
- •17. Have made a donation of blood or had significant blood loss within 56 days prior to the assigned first dose of study drug.
- •18. Have participated in another clinical trial within 28 days prior to the assigned first dose of study drug.
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