ISRCTN36145549已完成1 期
A phase 1, open-label trial to evaluate the effects of single and multiple doses, CYP3A4 inhibition, and food on the pharmacokinetics of terguride in healthy subjects with known CYP2D6 genotypes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 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
入排标准
- 性别
- All
入选标准
- •1. Medically healthy adults
- •2. Aged between 18-60 years inclusive at the time of screening
- •3. Non-smoker
- •4. Body mass index (BMI) = 18.5 and = 30.0 kg/m2 at screening
- •5. Known CYP2D6 genotype
- •6. No clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI
- •7. Appropriate contraception
- •8. Able to swallow multiple capsules and/or tablets
- •9. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
排除标准
- •1. Mentally or legally incapacity
- •2. History or presence of clinically significant medical or psychiatric condition or disease
- •3. Alcoholism or drug abuse within the past 2 years
- •5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug, itraconazole, metoclopramide (MCP) or related compounds
- •6. Female subjects who are pregnant or lactating
- •7. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antihepatitis C virus (antiHCV) antibodies screen
- •8. QTcF interval is >450 msec (males) or >470 msec (females) or clinically significant ECG findings at screening
- •9. Creatinine clearance < 80 mL/min
- •10. Drugs / herbals known to be significant inducers of CYP enzymes and/or P-gp
- •11. Diet incompatible with the on-study diet, lactose intolerance
- •12. Major surgery within 60 days prior to the first dose of study drug and throughout the study
- •13. Donation of blood or plasma within 90 days prior to the first dose of study drug
- •14. Donation of bone marrow within the last 6 months prior to the first dose of study drug
- •15. Participation in another clinical trial within 90 days prior to the first dose of study drug
研究者
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