NCT01869686

Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose

An Open-label Study to Evaluate the Concentration of Denosumab in Seminal Fluid After a Single Subcutaneous Injection in Healthy Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects will be followed by a 105 day treatment-free follow-up period.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	Denosumab	60 mg

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-06-05
• Last updated: 2014-11-06
• Results posted: 2014-09-26

Locations

1 site across 1 country: United States