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NCT01293487 · ClinicalTrials.gov registry record · Phase 1
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01293487: Completed Phase 1 study, sponsored by Pfizer.
NCT01293487 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01293487, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
Primary Outcome
Dose-limiting or intolerable treatment related AEs was defined as any of the following criteria occurred in 2 or more participants: Serious adverse events, Increased liver transaminases, Increased bilirubin (in absence of ALT/AST elevations, allergic / hypersensitivity reactions, vasculitis, Musculoskeletal pain, Increased serum creatinine, Diarrhea, enteritis or nausea, Prolongation of QTcF interval or any other criteria If considered appropriate by the Medical Monitor and Investigator. A dose
Interventions
- BIOLOGICAL RN564
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2012-05-24 |
| Phase | Phase 1 |
What the finished NCT01293487 record still lists
NCT01293487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 1 intervention - of which RN564 is the first listed.
NCT01293487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01293487 about?
NCT01293487 is a clinical study titled "Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.". The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
What is the current status of trial NCT01293487?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2011-04-01. Estimated completion is 2012-05-24.
What interventions are being tested in trial NCT01293487?
The interventions under investigation include: RN564 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01293487?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01293487's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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