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

NCT01592890 | Completed Phase 1

• 2 other identifiers: BP278542011-004597-28
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Elimination: urinary and fecal recovery of total radioactivity

  Pre-dose and up to approximately Day 18 post-dose

• Plasma concentrations of RO4917523

  Pre-dose and up to approximately Day 18 post-dose

Secondary Outcomes (2)

• Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling

  Pre-dose and up to approximately Day 18 post-dose

• Absolute bioavailability: Area under the concentration-time curve (AUC)

  Pre-dose and up to approximately Day 18 post-dose

Study Arms (1)

[14C]-labeled RO4917523

EXPERIMENTAL

Drug: RO4917523

Interventions

RO4917523 DRUG

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

[14C]-labeled RO4917523

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)