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
- Conditions
- Diabetes10012653Diabetic retinopathy
- Registration Number
- NL-OMON51247
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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,
agree 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize mass balance, rates and routes of elimination of [14C]-labeled<br /><br>RO6868847, using conventional analytical methods (and accelerator mass<br /><br>spectrometry [AMS] if necessary).<br /><br><br /><br>To assess the pharmacokinetics (PK) of total drug-related [14C]-radioactivity,<br /><br>[12C] RO6868847 and its metabolite(s), as appropriate, using conventional<br /><br>analytical methods (and AMS if necessary).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To identify and quantify the metabolic profiles of RO6868847 in plasma, blood<br /><br>pellet (if appropriate), urine and feces, based on [14C]-radioactive metabolic<br /><br>profiling, and characterize any major metabolite(s), using conventional<br /><br>analytical methods (and AMS if necessary).<br /><br><br /><br>To assess the safety and tolerability of a single oral dose of [14C/12C]<br /><br>RO6868847 in healthy participants.</p><br>