Status:
COMPLETED
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Lead Sponsor:
Novartis
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
40-70 years
Phase:
PHASE1
Brief Summary
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
Eligibility Criteria
Inclusion
- Healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Body mass index (BMI) within the range of 19 to 32.
Exclusion
- Smokers who report cigarette use of \>= 5 cigarettes per day.
- Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening.
- Previous osteoporosis treatment
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00676312
Start Date
May 1 2008
Last Update
December 11 2008
Active Locations (1)
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1
Novartis Investigative site
Basel, Switzerland