Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT01592890
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO4917523
Drug[14C]-labeled RO4917523, single oral dose
Primary outcomes
-
Elimination: urinary and fecal recovery of total radioactivity
Time frame: Pre-dose and up to approximately Day 18 post-dose
-
Plasma concentrations of RO4917523
Time frame: Pre-dose and up to approximately Day 18 post-dose
Secondary outcomes
-
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
-
Absolute bioavailability: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to approximately Day 18 post-dose
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 7, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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