Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered
timeFrame: Up to Day 17
measure: Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax
timeFrame: Up to Day 17
Secondary outcomes:
measure: Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces
timeFrame: Up to Day 17
measure: Incidence of adverse events
timeFrame: Up to 28 days after the last dose of study drug
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: