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
  Purpose

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.


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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 2014
Health Authority: Netherlands: CCMO, Centrale Commissie Mensgebonden Onderzoek

ClinicalTrials.gov processed this record on October 20, 2014