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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592890
• Other study ID #: BP27854
• Secondary ID: 2011-004597-28
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2012
• Last updated: November 1, 2016
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: CCMO, Centrale Commissie Mensgebonden Onderzoek
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917523
[14C]-labeled RO4917523, single oral dose
• RO4917523
[13C]-labeled RO4917523, single intravenous tracer dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination: urinary and fecal recovery of total radioactivity		Pre-dose and up to approximately Day 18 post-dose	No
Primary	Plasma concentrations of RO4917523		Pre-dose and up to approximately Day 18 post-dose	No
Secondary	Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling		Pre-dose and up to approximately Day 18 post-dose	No
Secondary	Absolute bioavailability: Area under the concentration-time curve (AUC)		Pre-dose and up to approximately Day 18 post-dose	No