DRKS00022547已完成1 期
Relative contribution of CYP3A and CYP2C19 to the oral clearance of voriconazole
niversitätsklinikum Heidelberg0 个研究点目标入组 17 人开始时间: 2020年8月6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
- 17
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Age 18-50 years (y) inclusive at the time of consent,
- •2. Males and females of child-bearing potential who are willing to use a highly effective method of contraception during the treatment and 7 days after last administration of the investigational medicinal product (IMP) or women not of child-bearing potential (WNCBP) or individuals who are convincingly sexually abstinent,
- •3. Participation in a genotyping study (K093) to determine CYP2C19 genotypes,
- •4. Understanding, ability, and willingness to fully comply with trial interventions and restrictions, and
- •5. Ability to provide written, personally signed and dated informed consent to participate in the trial, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, prior to any trial-related interventions.
排除标准
- •At the time of SCR:
- •1. Clinically significant or relevant abnormalities in the medical history,physical examination, and laboratory evaluation as assessed by the investigator,
- •2. Any medical disorder that may require significant treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interventions,
- •3. Clinically relevant ongoing or clinically relevant history of physical or psychiatric illness as judged by the investigator,
- •4. Pregnancy or breast feeding,
- •5. Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of VRC, MDZ and OMZ.
- •6. Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies (except mild forms of hay fever),
- •7. Any known allergies to VRC, MDZ and OMZ as well as any allergies to any triazole derivatives (ATC J02AC).
- •8. Clinically relevant findings in any of the following investigations at SCR. Minor deviations of laboratory values from the normal range can be acceptable, if judged by the investigator to be of no clinical relevance for this trial.
- •Hemoglobin (Hb) < 12 g/dl (males) or < 11 g/dl (females),
- •eGFR< 60 ml/min,
- •Bilirubin > upper limit of normal (ULN) x 1.2, In case of suspected Gilbert’s disease: non-fasting total bilirubin = ULN x 1.2 and fasting total bilirubin = ULN x 1.5 are acceptable.
- •Alanine aminotransferase (ALT)> ULN x 1.1,
- •Aspartate aminotransferase (AST) > ULN x 1.2, and
- •Creatine kinase (CK) not within normal limits (Volunteers with CK elevations between ULN and ULN x 3 may be included if troponin T is negative)
- •9. A positive result in the drug screening test at SCR,
- •10. Use of any medication with active ingredients or substances known to induce or inhibit drug metabolizing enzymes (CYP3A4, CYP2C19; prescription medication, non-prescription medication including herbal preparations) within 5 times the expected half-life (t1/2) prior to the expected date of first dose of IMP except hormonal contraception and thyroid hormones,
- •11. Relevant consumption of grapefruit or products of grapefruit within 7 days prior to the expected date of first dose of IMP and expected noncompliance to refrain from the products until visit 2 of this trial is completed,
- •12. Pathologic alcohol consumption as judged by the investigator,
- •13. Use of an IMP within 30 days prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
- •At visit 1, prior to dosing:
- •14. Use of any medication with active ingredients or substances known to induce or inhibit drug metabolizing enzymes (CYP3A4, CYP2C19; prescription medication, non-prescription medication including herbal preparations) within 5 times the expected half-life (t1/2) prior to the date of first dose of IMP except hormonal contraception and thyroid hormones,
- •15. Relevant consumption of grapefruit or products of grapefruit or products containing St. John’s Wort within 7 days prior to the expected date of first dose of IMP and expected noncompliance to refrain from the products until visit 2 of this trial is completed,
- •16. Use of an IMP within 30 days prior to receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
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