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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

35 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered

    Time frame: Up to Day 17

  2. Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax

    Time frame: Up to Day 17

Secondary outcomes

  1. Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces

    Time frame: Up to Day 17

  2. Incidence of adverse events

    Time frame: Up to 28 days after the last dose of study drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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