Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics After Single Administration of 200 mg [14C]Rogaratinib (Oral Solution) in Healthy Male Subjects

Bayer1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2018年4月6日最近更新: 2018年8月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Bayer
入组人数: 6
试验地点: 1
主要终点: Cmax of rogaratinib in plasma

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For further clinical development, human mass balance data are required to elucidate the absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 21 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•The written informed consent must be signed before any study specific tests or procedures are done
•Age: 21 to 65 years (inclusive) at the first screening examination visit
•Body mass index (BMI) 18.5 to 32.0 kg/m2 (both inclusive) and a total body weight of 55 to 100 kg (both inclusive)
•Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, laboratory tests, physical, cardiac and full ophthalmologic examination
•Subjects of reproductive potential with a partner of child-bearing potential must agree to use adequate contraception when sexually active. This applies from signing of the ICF until 3 months after the study drug administration. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female, should not be used together) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception. Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously. This is not required if safe contraception is achieved by a permanent method, such as vasectomy of the subject or bilateral fallopian tube blockage of the subject's partner; OR if the subject has no requirement for contraception (e.g. same sex partners).
•Ability to understand and follow study-related instructions

排除标准

•Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
•Known or suspected hypersensitivity to rogaratinib or to excipients in the formulation, or to any FGFR inhibitor
•Known severe allergies, non-allergic drug reactions, or multiple drug allergies
•Relevant diseases within the last 4 weeks prior to the first study drug administration
•Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
•Presence of high myopia or pathological myopia (defined as spherical equivalent ≥ 6.00D), or any retinal abnormalities consistent with pathologic myopia
•Known recent use of recreational drugs (last 3 months), suspicion of drug or alcohol abuse, or positive results of the urine drug or alcohol screen at screening or baseline
•Use of any medication within 14 days before administration of the study drug except paracetamol
•Smoking more than 5 cigarettes daily
•Exposure to radiation for diagnostic reasons (except dental X rays and plain X rays of thorax and bony skeleton [excluding spinal column]), during work or during participation in a clinical study in the period of 1 year prior to screening
•Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of > 1.1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of > 2.1 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)
•Previous (within the preceding 3 months; end of previous study to first treatment of the current study) or concomitant participation in another clinical study with investigational medicinal product(s)

研究组 & 干预措施

Rogaratinib (BAY1163877)

Experimental

Healthy male subjects

干预措施: Rogaratinib (BAY1163877) (Drug)