NL-OMON50753已完成不适用
An open-label study to investigate the effects of emvododstat on the pharmacokinetics of CYP2D6 and BCRP substrates in healthy volunteers - Emvododstat (PTC299) DDI study with CYP2D6 and BCRP substrates
适应症
试验速览
- 阶段
- 不适用
- 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
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Healthy adult, non-smokers (no use of tobacco products within 6 months prior
- •to Screening), >=18 and <=65 years of age.
- •2. Body mass index >18.0 and <30.0 kg/m2 and body weight >=50.0 kg and <=110.0 kg.
- •3. Ability to swallow tablets
- •4. Women of child-bearing potential (as defined in (CTFG 2014)) must have a
- •negative pregnancy test at Screening and agree to abstinence or the use at
- •least one of the following highly effective forms of contraception (with a
- •failure rate of <1% per year when used consistently and correctly) in addition
- •to barrier method for their sexual partner. Contraception or abstinence must be
- •continued for the duration of the study following discharge from the hospital,
- •and for up to 180 days after the last dose of study drug:
- •- Combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation:
- •- Intravaginal
- •- Transdermal
- •- Progestogen-only hormonal contraception associated with inhibition of
- •- Injectable
- •- Implantable
- •- Intrauterine device
- •- Intrauterine hormone-releasing system
- •- Vasectomized partner with confirmed azoospermia
- •All females will be considered of child-bearing potential unless they are
- •postmenopausal (at least 12 months consecutive amenorrhea in the appropriate
- •age group without other known or suspected cause) or have been sterilized
- •surgically (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
- •5. Sexually active and fertile males must use a condom during intercourse while
- •taking study drug and for 90 days after stopping study drug and should not
- •father a child in this period. A condom is required to be use by vasectomized
- •men in order to prevent delivery of the drug via seminal fluid.
- •Further criteria apply
排除标准
- •1. For Part 1 (CYP2D6 substrate), subjects who are poor metabolizers of CYP2D6
- •isoenzymes are excluded.
- •2. Pregnant or lactating subjects or those sexually active subjects who are
- •unwilling to comply with proper birth control methods; females of child-bearing
- •potential must have a negative pregnancy test at Screening and during the
- •Baseline Visit.
- •3. Aspartate aminotransferase or alanine aminotransferase above the upper limit
- •of normal (ULN) at the time of Screening or Baseline. Values above ULN may be
- •allowed if considered not clinically significant at the discretion of the
- •Investigator.
- •4. International normalized ratio >=1.5×ULN at time of Screening or Baseline or
- •clinically significant bleeding, as determined by the Investigator.
- •5. Serum creatinine >=1.5×ULN at time of Screening or Baseline.
- •Further criteria apply
研究者
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