NL-OMON51079已完成不适用
Single center, open-label study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO6889450 in healthy male volunteers - [14C]-labeled RO6889450 ADME study
F. Hoffman-La Roche Ltd0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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 99（—）
入选标准
- •1. Able and willing to provide written informed consent and to comply with the
- •study protocol according to International Council for Harmonisation (ICH) and
- •local regulations.
- •2. Healthy participants aged 18 to 55 years of age, inclusive, at the time of
- •signing the ICF.
- •3. Male participants who are overtly healthy (defined by absence of evidence of
- •any active or chronic disease) as determined by medical evaluation including:
- •A detailed medical and surgical history
- •A complete physical examination
- •Vital signs
- •12-lead ECG
- •Hematology
- •Blood chemistry
- •Serology and urinalysis
- •4. Fluent in the language of the Investigator and study staff (Dutch or
- •English), and able to communicate with the study staff.
- •5. Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive at screening.
- •6. Male participants
- •During the treatment period and for at least 90 days after the final dose of
- •RO6889450 agreement to:
- •Remain abstinent (refrain from heterosexual intercourse) or use contraceptive
- •measures such as a condom plus an additional contraceptive method that together
- •result in a failure rate of <1% per year, with a female partner who is not
- •pregnant and of childbearing potential (WOCBP, as defined in Section 1 of
- •Appendix 5).
- •Refrain from donating sperm.
排除标准
- •1. Any condition or disease detected during the medical interview/physical
- •examination that would render the participant unsuitable for the study, place
- •the participant at undue risk or interfere with the ability of the participant
- •to complete the study, as determined by the Investigator.
- •2. Disorders of the central nervous system (CNS), psychiatric disorders,
- •behavioral disturbances (e.g., cerebrovascular events, earlier, or current
- •major depression, post-traumatic stress disorder, anxiety, bipolar disorder,
- •severe migraine, Parkinson*s disease, attention deficit hyperactivity disorder).
- •3. Any personal or familial history (1st degree) of seizures, epilepsy, or
- •other convulsive condition; or previous significant head trauma, or other
- •factors predisposing to seizures.
- •4. History or evidence of any medical condition potentially altering the
- •absorption, metabolism, or elimination of drugs.
- •5. History of any clinically significant gastrointestinal, renal, hepatic,
- •bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological,
- •hematological or allergic disease, metabolic disorder, hypofertility, cancer,
- •or cirrhosis.
- •6. Sensitivity to any of the study treatments, or components thereof, or drug
- •or other allergy that, in the opinion of the Investigator, contraindicates the
- •participation in the study. Any major illness within one month before the
- •screening examination or any febrile illness within one week prior to screening
- •and up to first study drug administration.
研究者
相似试验
已完成
不适用
Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-radio-labeled RO4602522 in Healthy Male Volunteers10029305Alzheimer's diseasedementiaNL-OMON36882Hoffmann-La Roche6
已完成
不适用
A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of QBW251 following a single oral dose of [14C]QBW251 in healthy male subjects at steady state conditions.ongaandoeningenCOPDlung diseasesNL-OMON46062ovartis Pharma AG6
已完成
不适用
A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LNP023 following a single oral dose of [14C]LNP023 in healthy male/female subjects.NL-OMON48316ovartis6
已完成
不适用
A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state.NL-OMON49324ovartis7
已完成
不适用
A single-center, open-label study to evaluate the distribution, metabolism, and excretion (DME) and pharmacokinetics of MIJ821 following a single intravenous (i.v.) infusion of [14C]MIJ821 in healthy male participants.mental disorderNL-OMON51743ovartis6