drugset / Trial / NCT01294397

Effects of Denosumab on the Pharmacokinetics of Etanercept

NCT01294397

Phase 1 Terminated 19 enrolled Amgen
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2011-03
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous
Subject Etanercept Protein / enzyme biologic 50 mg Subcutaneous