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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO5285119

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179866

2014-000277-40 (EudraCT Number)

BP29279

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 1 patient group

[14C]-labeled RO5285119

Experimental group

Description:

Single oral dose - drinking solution

Treatment:

Drug: RO5285119