Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Hoffmann-La Roche
Study ID
NCT03596632
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Fenebrutinib — DRUG
    200-mg (100 µCi) oral solution 14C/12C\]-fenebrutinib

Study Details

The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.

Key Dates

Start date
Jul 27, 2018
Status verified
Dec 2018
Primary completion
Aug 23, 2018
Completion
Aug 23, 2018

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single Oral Solution Dose
    Single 200-mg (approximately 100-µCi) oral solution dose of \[14C/12C\]-fenebrutinib under fasted conditions.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose) [ Time Frame: Screening to end of study (approximately 35 days post-dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research Unit, IncMadisonWisconsin53704-

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Covance Clinical Research Unit, Inc· Madison, WI

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