Covance Clinical Research Unit, Inc
Madison, Wisconsin, 53704, United States
NCT Number: NCT03596632
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
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Notify Me18 year–60 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib
Other names: RO7010939
Time frame: Screening to end of study (approximately 35 days post-dose)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time frame: Screening up to Day 31
Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.
Time frame: Day -1, 28
Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems.
Time frame: Screnning, Day -1, 2, 4, 28
Laboratory analysis include chemistry panel, complete blood count and urinalysis.
Time frame: Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31
Hoffmann-La Roche
Industry
A Phase 1 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers
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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