Clinical trial NCT01592890: A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Elimination: urinary and fecal recovery of total radioactivity
timeFrame: Pre-dose and up to approximately Day 18 post-dose
measure: Plasma concentrations of RO4917523
timeFrame: Pre-dose and up to approximately Day 18 post-dose
Secondary outcomes:
measure: Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling
timeFrame: Pre-dose and up to approximately Day 18 post-dose
measure: Absolute bioavailability: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to approximately Day 18 post-dose
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: