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CompletedNCT01592890Updated Nov 2, 2016

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

A Phase 1 interventional study of RO4917523 and RO4917523 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]-labeled RO4917523

    Drug: RO4917523

Interventions

  • DrugRO4917523

    \[14C\]-labeled RO4917523, single oral dose

  • DrugRO4917523

    \[13C\]-labeled RO4917523, single intravenous tracer dose

06

What researchers measure

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

07

Study locations

1 site
  • Zuidlaren, 9471 GP, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01592890
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
May 7, 2012
Start date
Apr 2012
Primary completion
May 2012
Completion
May 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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