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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5285119

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuidlaren, Netherlands, 9471 GP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-labeled RO5285119; Single oral dose - drinking solution	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered	Up to Day 17
Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax	Up to Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to 28 days after the last dose of study drug
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP29279; 2014-000277-40 (EudraCT Number)