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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
70 participants (actual)
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
Design
Randomized · Double masking
Countries
1 country

Canada

Start
Aug 2009
Primary completion
Feb 2011
Completion
Feb 2011
First posted
6 Aug 2009 (estimated)
Last update posted
23 Mar 2011 (estimated)
Conditions
Muscular Atrophy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 1

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

    NCT00952887

    Aug 2009 to Feb 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ACE-031Biological
  • PlaceboBiological

Arms2

  • Experimental

    ACE-031

    8 dosing groups

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women

    Time frame · 6.5 months

Secondary outcomes(1)
  1. To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031

    Time frame · 6.5 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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