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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: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
 Drug: RO4917523
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [14C]-labeled RO4917523 Drug: RO4917523
[14C]-labeled RO4917523, single oral dose
Drug: RO4917523
[13C]-labeled RO4917523, single intravenous tracer dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592890

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01592890     History of Changes
Other Study ID Numbers: BP27854, 2011-004597-28
Study First Received: May 4, 2012
Last Updated: June 3, 2013
Health Authority: Netherlands: CCMO, Centrale Commissie Mensgebonden Onderzoek

ClinicalTrials.gov processed this record on June 17, 2013