Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT02179866
A Single-center Study to Investigate How Quickly and to What Extent a Radioactive Dose of RO5285119 is Absorbed, Metabolized and Eliminated From the Body of Healthy Male Volunteers
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.
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Notify MeKey information
Conditions
Age range
35 year–64 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO5285119
DrugSingle oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1
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
Time frame: Up to Day 17
-
Incidence of adverse events
Time frame: Up to 28 days after the last dose of study drug
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jul 2, 2014
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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