Status:
COMPLETED
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Muscular Atrophy
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on ...
Eligibility Criteria
Inclusion
- Postmenopausal
- Body mass index (BMI) of ≥ 18.5 to \< 32.
Exclusion
- History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas
- History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
- History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
- Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).
- Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1.
- Donation or significant loss of blood within 2 months prior to Day 1.
- Hormone replacement therapy within 3 months prior to Day 1.
- Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1.
- Systemic glucocorticoid therapy within 6 months prior to Day 1.
- Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1.
- Previous treatment with ACE-031.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00952887
Start Date
August 1 2009
End Date
February 1 2011
Last Update
March 23 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Acceleron Investigative Site
Montreal, Canada
2
Acceleron Investigative Site
Québec, Canada