NCT02802670

A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, non-randomized study to determine the excretion kinetics and mass balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing approximately 100 microcuries of \[14C\] labeled GDC-0810 using conventional absorption, metabolism, and excretion (AME) methodology. The entire duration of the study is up to approximately 8 weeks.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-GDC-0810	Participants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of \[14C\]-labeled GDC-0810 on Day 1.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-06-16
• Last updated: 2016-06-16

Locations

1 site across 1 country: United States