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Completed

NCT Number: NCT01592890

A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers

This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.

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Key information

Conditions

Age range

18 year–65 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

  • Male adults, 18 to 65 years of age inclusive
  • Body mass index (BMI) 18.0 to 32.0 kg/m2
  • Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
  • Medical history without major pathology
  • Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug

Exclusion criteria

  • History of relevant drug and or food allergies
  • Smoking (within 60 days prior to drug administration until the follow-up visit)
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
  • Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
  • Infrequent bowel movements (less than once per 2 days)
  • Participation in another ADME study with a radiation burden >0,1 mSv in the period of 1 years before the start of the study
  • Positive screen for drugs of abuse
  • Average intake of more than 24 units of alcohol per week
  • Positive for hepatitis B, hepatitis C or HIV infection

Treatment and study plan

RO4917523

Drug

[14C]-labeled RO4917523, single oral dose

Primary outcomes

  1. Elimination: urinary and fecal recovery of total radioactivity

    Time frame: Pre-dose and up to approximately Day 18 post-dose

  2. Plasma concentrations of RO4917523

    Time frame: Pre-dose and up to approximately Day 18 post-dose

Secondary outcomes

  1. Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling

    Time frame: Pre-dose and up to approximately Day 18 post-dose

  2. Absolute bioavailability: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to approximately Day 18 post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 7, 2012
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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