Open-label, non-randomized study investigating the excretion balance, Pharmacokinetics, and metabolism of a single oral dose of [14c]-labeled ro6868847 in healthy male participants - Excretion balance, PK, and metabolism of [14C]-labeled RO6868847

F. Hoffmann-La Roche Ltd0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月9日

研究概览

暂无简介。

•1. Able and willing to provide written informed consent and to comply with the
•study protocol according to ICH and local regulations.
•2. Male participants aged 35 to 64 years of age (inclusive), at screening.
•3. Healthy participants. Health status is defined by absence of evidence of any
•active or chronic disease following a detailed medical and surgical history, a
•complete physical examination including vital signs, 12-lead electrocardiogram
•(ECG), hematology, clinical chemistry, serology, coagulation, and urinalysis.
•4. Body weight > 50 kg and body mass index within the range 18 to 30 kg/m2
•(inclusive), at screening.
•5. Male participants who, for 3 months after the dosing of [14C/12C] RO6868847,
•- 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 partner who is a woman of
•childbearing potential
•- With a pregnant female partner, remain abstinent (refrain from heterosexual
•intercourse) or use contraceptive measures such as a condom to avoid exposing
•the embryo to RO6868847
•- Refrain from donating sperm.

•1. History of any clinically significant gastrointestinal, renal, hepatic,
•broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological,
•hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis.
•2. Concomitant disease or condition that could interfere with, or treatment of
•which might interfere with, the conduct of the study, or would, in the opinion
•of the Investigator, pose an unacceptable risk to the participant in this
•study, including but not limited to any major illness within 1 month prior to
•screening or any febrile illness within 1 week prior to screening and up to
•study drug administration.
•3. 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 (with the exception of uncomplicated appendectomy and
•hernia repair).
•4. History or presence of clinically significant ECG abnormalities based on the
•average of the triplicate ECG recordings (e.g., PQ/PR interval > 210 ms, QTcF >
•450 ms) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery
•disease, cardiomyopathy, congestive heart failure, family history of congenital
•long QT syndrome, family history of sudden death).
•5. History of malignancy.
•Further criteria apply

发起方