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NCT01869686 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01869686 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 12 participants.
The verdict
NCT01869686, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01869686
The ClinicalTrials.gov registry entry for NCT01869686 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Denosumab is the first listed.
NCT01869686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01869686 about?
NCT01869686 is a clinical study titled "Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose". 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.
What is the current status of trial NCT01869686?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01869686?
The interventions under investigation include: Denosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01869686?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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