Trial · Interventional
CompletedPhase 1Registry dataA 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
- Ph 1
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
NCT00952887Aug 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.
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)
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
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