NCT02179866CompletedPhase 1
SINGLE-CENTER, OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO5285119 IN HEALTHY MALE SUBJECTS
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 6
- Primary Endpoint
- Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered
Study Overview
Brief Summary
This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male participants, 35 to 64 years of age, inclusive
- •For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug
- •Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug
Exclusion Criteria
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- •Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- •Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to a subject
- •History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease
- •History of myopathy or muscle disorder
- •History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
- •Any CYP3A inhibitor within 2 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
- •Any CYP3A inducer within 4 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
- •Infrequent bowel movements (less than once per 24 hours on average)
- •Regular work with ionizing radiation or radioactive material
Arms & Interventions
[14C]-labeled RO5285119
Experimental
Single oral dose - drinking solution
Intervention: RO5285119 (Drug)
Outcomes
Primary Outcomes
Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered
Time Frame: Up to Day 17
Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax
Time Frame: Up to Day 17
Secondary Outcomes
- Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces(Up to Day 17)
- Incidence of adverse events(Up to 28 days after the last dose of study drug)
Investigators
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