Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
NCT01293487
ABOUT THIS STUDY
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- Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.
- Evidence or history of any underlying condition, other than primary osteopenia, that
affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
- Subjects with pre-existing periodontal/dental disease or those who have undergone
invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior
to Day -1.
- If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of
the three QTcF values should be used to determine the subject's eligibility.
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Descriptive Information | ||||
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Brief Title ICMJE | Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men. | |||
Official Title ICMJE | A Phase I Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of RN564 In Women With Osteopenia And In Healthy Men | |||
Brief Summary | The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Biological: RN564
Intravenous, single dose with experimental dose | |||
Study Arms ICMJE | Experimental: Arm 1
Intervention: Biological: RN564 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 68 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 55 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01293487 | |||
Other Study ID Numbers ICMJE | B1151001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |