A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials
| City: |
|
Tempe |
| State: |
|
Arizona |
| Zip Code: |
|
|
| Conditions: |
|
Anemia |
| Purpose: |
|
The purpose of this study is to find out whether ACE-536 can be safely given to patients.
This study will also look to see if ACE-536 increases red blood cells, the cells that carry
oxygen in the body.
|
| Study Summary: |
|
|
| Criteria: |
|
Key Inclusion Criteria:
- Postmenopausal women
- Body Mass Index (BMI) of 20 - 32 kg/m2.
Key Exclusion Criteria:
- History of hypertension
- Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit,
Aranesp, etc.) within 6 months prior to Day 1
- History of clinically significant cardiac, endocrine, hematologic, hepatic, immune,
metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or
other disease
- Surgery within 3 months (other than minor cosmetic surgery or minor dental
procedures)
- Subject has received treatment with another investigational drug, or approved therapy
for investigational use within 1 month prior to Day 1, or if the half-life of the
previous product is known, within 5 times the half-life prior to Day 1, whichever is
longer
|
| NCT ID: |
|
NCT01432717 |
| Primary Contact: |
|
N/A |
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Tempe, Arizona United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|