ISRCTN57377850已完成1 期
A Phase I, open-label, fixed-sequence study to evaluate the effect of a single dose of cyclosporine on the single-dose pharmacokinetics of pralsetinib in healthy subjects
Roche (Switzerland)0 个研究点目标入组 15 人开始时间: 2021年10月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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. Within BMI range 18.5 to 30.0 kg/m², inclusive
- •2. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory profiles, 12-lead ECG, and vital signs
- •3. Clinical laboratory evaluations (including chemistry panel [fasted at least 10 hours], complete blood count [CBC], and urinalysis [UA] with complete microscopic analysis within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- •4. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1) (does include alcohol; Appendix A) and agrees to abstain from recreational drug use throughout the study, from screening until follow-up
- •5. Females will not be pregnant or breastfeeding, and must be either postmenopausal (at least 12 months without a period [i.e., amenorrhea]; in a woman at least 45 years of age and documented by a serum follicle-stimulating hormone [FSH] level consistent with postmenopausal status [i.e., =40 IU/l] in the absence of a reversible medical iatrogenic cause), or surgically sterile
- •6. Males will either be sterile or agree to use contraception
- •7. Receive an explanation of the mandatory {WGS} [and/or] {WES} component of the study
排除标准
- •Current exclusion criteria as of 06/06/2023:
- •1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
- •2. History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- •3. History of significant hypersensitivity, idiosyncratic reaction, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- •4. Use of oral antibiotics to treat an active infection within 4 weeks or intravenous antibiotics to treat an active infection within 8 weeks prior to Screening
- •5. History of stomach or intestinal surgery or resection prior to first dosing that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed
- •6. History or presence of an abnormal ECG, which, in the Investigator’s opinion, is clinically significant
- •7. History of alcoholism or drug addiction within 2 years prior to Check-in (Day -1)
- •8. History of active or latent TB, regardless of treatment history, or has a positive screening test for latent mycobacterium infection by QuantiFERON® TB Gold (Appendix A). Indeterminate results may be confirmed by repeat or by a purified protein derivative (PPD) skin test 9. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, or administered treatment with another investigational drug within 5 times the elimination half-life, if known (if marketed product) or within 30 days (if the elimination half-life is unknown) prior to first dose of pralsetinib (Day 1). The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study
- •10. Receipt of any vaccines (including coronavirus disease-2019 [COVID-19], seasonal flu, and H1N1 vaccines) within 14 days prior to Screening, unless deemed acceptable by the Investigator and Sponsor
- •11. Prior exposure to pralsetinib or other RET inhibitors
- •12. Has a positive pregnancy test or is lactating (females only)
- •13. Has a positive urine drug or breath or urine alcohol result at Screening or Check-in
- •14. Has a positive urine cotinine result at Screening or Check-in
- •15. Use of any prescription medications/products within 14 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator
- •16. Use of any over-the-counter, nonprescription preparations (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to Check-in (Day 1), unless deemed acceptable by the Investigator. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee to treat AEs. Hormone replacement therapy will not be allowed
- •17. Use of any drugs known to be a strong inhibitor and/or inducer of CYP1A2, CYP2D6, CYP
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