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

NCT ID: NCT02179866

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

[14C]-labeled RO5285119

Single oral dose - drinking solution

Group Type: EXPERIMENTAL

RO5285119

Intervention Type: DRUG

Single 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

Interventions

RO5285119

Single 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

2014-000277-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP29279

Identifier Type: -

Identifier Source: org_study_id