Overview
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.Phase:
Phase 1Details
Lead Sponsor:
Novartis
Criteria
Inclusion Criteria:- 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 Criteria:
- 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