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

NCT01869686 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-11-06

Study results available
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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

BIOLOGICAL

Denosumab

60 mg

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869686 on ClinicalTrials.gov