Diabetes Diabetic retinopathy
Conditions
Interventions
The volunteer will be given one dose of 300 mg RO6868847 as a drink on Day 1
after having fasted overnight for at least 10 hours. The volunteer will be
given 50 milliliter (mL) of RO6868847 to swall
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize mass balance, rates and routes of elimination of [14C]-labeled RO6868847, using conventional analytical methods (and accelerator mass spectrometry [AMS] if necessary). To assess the pharmacokinetics (PK) of total drug-related [14C]-radioactivity, [12C] RO6868847 and its metabolite(s), as appropriate, using conventional analytical methods (and AMS if necessary). | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify and quantify the metabolic profiles of RO6868847 in plasma, blood pellet (if appropriate), urine and feces, based on [14C]-radioactive metabolic profiling, and characterize any major metabolite(s), using conventional analytical methods (and AMS if necessary). To assess the safety and tolerability of a single oral dose of [14C/12C] RO6868847 in healthy participants. | — |
Countries
Netherlands
Outcome results
None listed