Postmenopausal Osteoporosis
Conditions
Keywords
Osteoporosis, parathyroid hormone, pharmacodynamic, pharmacokinetic
Brief summary
This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
Interventions
DRUGPTH134
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours. | — |
Countries
Switzerland
Outcome results
None listed