Clinical Trials Directory

Trials / Terminated

TerminatedNCT01294397

Effects of Denosumab on the Pharmacokinetics of Etanercept

The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Amgen · Industry
Sex
Female
Age
45 Years – 80 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGEtanerceptAdministered by subcutaneous injection once a week
DRUGDenosumabAdministered by subcutaneous injection

Timeline

Start date
2011-03-01
Primary completion
2016-01-01
Completion
2016-01-01
First posted
2011-02-11
Last updated
2017-06-20
Results posted
2017-06-20

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01294397. Inclusion in this directory is not an endorsement.