TerminatedPhase 1ACTRN12610000379011

Single-ascending dose 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


Sponsor

Cephalon, Inc.

Enrollment

54 participants

Start Date

Jun 1, 2010

Study Type

Interventional

Conditions

Summary

The purpose of this study is to characterize the safety, pharmacokinetics, and pharmacodynamics of CEP 37251 following single ascending doses in healthy postmenopausal women. This study is intended to identify a dose of CEP-37251 having a sustained effect on biomarkers of bone resorption.


Eligibility

Sex: FemalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a new bone-health drug called CEP 37251 in postmenopausal women aged 40-75. It involves taking a single dose of the drug at increasing levels to check safety and how the body processes it. Women must weigh between 50-100kg and not be on hormone replacement therapy or bone medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

5 subcutaneous injection doses (sequentially) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 subcutaneous injection doses have been studied, an intravenous infusion dos

5 subcutaneous injection doses (sequentially) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 subcutaneous injection doses have been studied, an intravenous infusion dose of 0.3 mg/kg will be studied. At each dose level, subjects will be divided into 3 cohorts. The first cohort will consist of 2 subjects (1 subject receiving CEP-37251 and 1 subject receiving placebo), the second cohort will consist of 3 subjects (2 subjects receiving CEP-37251 and 1 subject receiving placebo), and cohort 3 will consist of 4 subjects (3 subjects receiving CEP-37251 and 1 subject receiving placebo). There will be a minimum of 30 minutes between the start of study drug administration for each subject within a cohort. Each subject in both the subcutaneous injection and intravenous infusion groups will receive one dose only. There will be a minimum of 1 week between dose administration of the 1st and subsequent cohort(s) for each dose level. There is no minumum wait time between administration of the 2nd and 3rd cohorts in each dose level. The 2nd and 3rd cohorts of a dose level can be dosed in non-sequential order and can be dosed on the same day.


Locations(1)

Australia

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ACTRN12610000379011