NCT01159873

Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Cephalon · Industry
• Sex: Female
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

Summary

Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.

Conditions

• Bone Loss
• Osteoporosis

Interventions

Type	Name	Description
DRUG	CEP-37251	up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) dose of 0.3 mg/kg will be studied.
DRUG	Placebo	up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of Placebo (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) placebo dose of 0.3 mg/kg will be studied.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-07-12
• Last updated: 2014-05-12

Locations

1 site across 1 country: Australia