Back to resultsA Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
Primary Purpose
Muscular Atrophy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
ACE-031
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscular Atrophy
Eligibility Criteria
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.
Sites / Locations
- Acceleron Investigative Site
- Acceleron Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACE-031
Placebo
Arm Description
8 dosing groups
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
Secondary Outcome Measures
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031
Full Information
NCT ID
NCT00952887
First Posted
August 4, 2009
Last Updated
March 22, 2011
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
1. Study Identification
Unique Protocol Identification Number
NCT00952887
Brief Title
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACE-031
Arm Type
Experimental
Arm Description
8 dosing groups
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ACE-031
Other Intervention Name(s)
ActRIIB-IgG1
Intervention Description
Either 2 or 3 subcutaneous doses of ACE-031 over a period of one month, or 7 subcutaneous doses of ACE-031 over a period of 3 months.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Either 2 or 3 subcutaneous doses of placebo over a period of one month, or 7 subcutaneous doses of placebo over a period of 3 months.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
Time Frame
6.5 months
Secondary Outcome Measure Information:
Title
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031
Time Frame
6.5 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Larouche, MD
Organizational Affiliation
Anapharm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acceleron Investigative Site
City
Montreal
Country
Canada
Facility Name
Acceleron Investigative Site
City
Quebec City
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
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