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

NCT02179866 | Completed Phase 1

• 2 other identifiers: BP292792014-000277-40
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• Incidence of adverse events

  Up to 28 days after the last dose of study drug

Study Arms (1)

[14C]-labeled RO5285119

EXPERIMENTAL

Single oral dose - drinking solution

Drug: RO5285119

Interventions

RO5285119 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

[14C]-labeled RO5285119

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)