progressive muscle disorder Spinal Muscular Atrophy
Conditions
Interventions
During the study you will receive radiolabeled RO7034067 after an overnight
fast (at least 10 hours no eating and drinking) as a drinking solution of 18
mL. After administration of the study compoun
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male subjects, 35 to 65 years of age (inclusive). A BMI between 18 to 30 kg/m2, inclusive.
Exclusion criteria
Exclusion criteria: 1. Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator. 2. History of any clinically significant gastrointestinal, renal, hepatic, broncho- pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize mass balance, routes and rates of elimination of [14C]-labeled RO7034067 To assess the pharmacokinetics (PK) of total drug related [14C]-radioactivity, RO7034067 and its metabolite(s) | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify and quantify the metabolic profiles of RO7034067 in plasma, blood pellet (if appropriate), urine and feces, based on [14C]-radioactive metabolic profiling, and characterize any major metabolite(s) | — |
Countries
Netherlands
Outcome results
None listed