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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592890
First received: May 4, 2012
Last updated: October 6, 2014
Last verified: October 2014

May 4, 2012
October 6, 2014
April 2012
May 2012   (final data collection date for primary outcome measure)
  • Elimination: urinary and fecal recovery of total radioactivity [ Time Frame: Pre-dose and up to approximately Day 18 post-dose ] [ Designated as safety issue: No ]
  • Plasma concentrations of RO4917523 [ Time Frame: Pre-dose and up to approximately Day 18 post-dose ] [ Designated as safety issue: No ]
  • Elimination: urinary and fecal recovery of total radioactivity [ Time Frame: up to approximately Day 18 post-dose ] [ Designated as safety issue: No ]
  • Plasma concentrations of RO4917523 [ Time Frame: Pre-dose and up to approximately Day 18 post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01592890 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Absolute bioavailability: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to approximately Day 18 post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: RO4917523
    [14C]-labeled RO4917523, single oral dose
  • Drug: RO4917523
    [13C]-labeled RO4917523, single intravenous tracer dose
Experimental: [14C]-labeled RO4917523
Interventions:
  • Drug: RO4917523
  • Drug: RO4917523
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01592890
BP27854, 2011-004597-28
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP