NCT03036501已完成1 期
Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled RO7034067 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of Dose Recovered as Total [14C]-radioactivity in Urine
研究概览
简要总结
This is an open-label, non-randomized study investigating the excretion balance, PK and metabolism of a single oral dose of [14C]-labeled Risdiplam (RO7034067) in healthy male participants. This study will assess the characterize mass balance, routes and rates of elimination of [14C]-labeled Risdiplam (RO7034067), using conventional analytical methods and assess the pharmacokinetics of total drug related [14C]-radioactivity, Risdiplam (RO7034067) and its metabolite(s).
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participants, 35 to 65 years of age (inclusive)
- •A body mass index between 18 to 30 kg/m^2 inclusive
- •Agreement to use two methods of contraception, during the treatment period and for at least 4 months after the last dose of study drug. One of the contraceptive methods must be a condom. The second contraceptive method must include one of the following: diaphragm or cervical cap, intra-uterine device or system, or oral, injected or implanted hormonal method of contraception.
- •No intention of donating sperm within 4 months of study drug administration
- •Able to participate and willing to give written informed consent and to comply with the study requirements and restrictions
- •Fluent in the language of the Investigator and study staff and able to communicate with the study staff
排除标准
- •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 in the opinion of the Investigator
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho- pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis
- •Participants with any clinically significant eye pathology affecting best-corrected visual acuity, or optic neuritis retinal abnormalities on spectral domain - optical coherence tomography and 7-field fundus color photography as assessed by an ophthalmologist
- •History or evidence of (neuro) muscular disorders
- •History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract
- •History or evidence of skin disorders, as assessed by a thorough skin examination of the whole body
- •History of malignancy in the past 5 years
- •A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
- •Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts
- •Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to study drug administration
- •History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
- •Clinically significant abnormalities in laboratory test results
- •Positive results on tests for human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis C virus or hepatitis B virus
- •Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drugs of abuse
- •Confirmed systolic blood pressure (SBP) greater than 150 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 95 or less than 50 mmHg
- •Confirmed (based on the average of at least 3 consecutive measurements) resting pulse rate greater than 100 or less than 40 bpm
- •Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the day of follow-up from the previous study
- •Smokers who regularly smoke more than 10 cigarettes daily or equivalent tobacco- containing products
- •Dietary restrictions that would prohibit the consumption of standardized meals
- •Use of any prohibited medications and food before study start and during the study
- •Participants under judicial supervision, guardianship or curatorship
- •Infrequent bowel movements (less than once per 24 hours on average)
- •Regular work with ionizing radiation or radioactive material
- •Participants who plan to attempt to father children within 4 months after study drug administration
研究组 & 干预措施
[^14C]-Risdiplam
Experimental
Participants will be administered with [^14C]-Risdiplam solution orally under fasted conditions on Day 1.
干预措施: [^14C]-Risdiplam (Drug)
结局指标
主要结局
Percentage of Dose Recovered as Total [14C]-radioactivity in Urine
时间窗: Day 1 to Day 36
Cumulative Urinary Amount of Total [14C]-Radioactivity in Urine
时间窗: Day 1 to Day 36
Percentage of Dose Recovered as Total [14C]-radioactivity in Feces
时间窗: Day 1 to Day 36
Maximum Observed Plasma Concentration (Cmax) of Risdiplam
时间窗: Day 1 to Day 36
Time to Maximum Observed Plasma Concentration of Risdiplam (Tmax)
时间窗: Day 1 to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 to Last Measurable Concentration Time Point (AUC0-last)
时间窗: Day 1 to Day 36
Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)
时间窗: Day 1 to Day 36
Apparent Terminal Elimination Half-Life (t1/2)
时间窗: Day 1 to Day 36
次要结局
- Percentage of Participants with Adverse Events(Up to 10 weeks)
- Percentage of Participants with Laboratory, ECGs, Ophthalmological Assessments, And Vital Signs Abnormalities(Up to 10 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male VolunteersHealthy VolunteerNCT01592890Hoffmann-La Roche6
已完成
1 期
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic MelanomaMalignant MelanomaNCT01164891Hoffmann-La Roche7
已完成
1 期
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)Solid TumorsNCT02828930Hoffmann-La Roche8
已完成
1 期
Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female SubjectsEpilepsyNCT03681158Sanofi5
已完成
1 期
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male SubjectsDisorders of Sphingolipid MetabolismHealthy VolunteersNCT05238714Genzyme, a Sanofi Company6