NCT01721993

Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women

Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01Fand T121E02F in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Thar Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in healthy postmenopausal women. The study is expected to identify a safe dose that can be further tested in subsequent multiple dose studies comparing the safety, PK and pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).

Conditions

• Healthy Postmenopausal Women

Interventions

Type	Name	Description
DRUG	T121
DRUG	Zoledronic acid

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-11-06
• Last updated: 2015-03-26

Locations

1 site across 1 country: United States