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NCT01294397 · ClinicalTrials.gov registry record · Phase 1
Effects of Denosumab on the Pharmacokinetics of Etanercept
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01294397 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 19 participants.
The verdict
NCT01294397, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).
Interventions
- DRUG Denosumab
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01294397
The ClinicalTrials.gov registry entry for NCT01294397 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 19 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 2 interventions - of which Denosumab is the first listed.
NCT01294397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01294397 about?
NCT01294397 is a clinical study titled "Effects of Denosumab on the Pharmacokinetics of Etanercept". The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum ob...
What is the current status of trial NCT01294397?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01294397?
The interventions under investigation include: Denosumab (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT01294397?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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