Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT01159873|
Recruitment Status : Terminated (Study has been stopped by sponsor decision)
First Posted : July 12, 2010
Last Update Posted : May 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bone Loss Osteoporosis||Drug: CEP-37251 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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.
|Placebo Comparator: 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.
- Characterize the Overall Safety Assessment of CEP-37251 [ Time Frame: 70 days ]Measurements include adverse events, laboratory results, vital sign measurements, electrocardiogram findings, physical examination findings, injection site evaluations, concomitant medication usage, immunophenotyping test results, and immunogenicity test results.
- Characterize the Overall Pharmacokinetic Profile of CEP-37251 [ Time Frame: 70 days ]Pharmacokinetic parameters include Cmax (Maximum Concentration) and AUC (Area Under the Curve) plasma concentration
- Characterize the Overall Pharmacodynamic Effect of CEP-37251 [ Time Frame: 70 days ]Pharmacodynamic effect as measured by markers of bone metabolism
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159873
|Cephalon Investigational Site|
|Adelaide, Australia, 5000|
|Study Director:||Sr. Director, Clinical Pharmacology and Experimental Medicine, MD||Cephalon|