A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Muscular Atrophy
• Interventions: Biological: ACE-031; Biological: Placebo

• Registration Number: NCT00952887
• Lead Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

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 muscle.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Postmenopausal
• Body mass index (BMI) of ≥ 18.5 to < 32.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACE-031	ACE-031	8 dosing groups
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women	6.5 months

Secondary Outcome Measures

Name	Time	Method
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031	6.5 months

Trial Locations

Locations (1)

Acceleron Investigative Site; 🇨🇦 Quebec City, Canada