None listed
Conditions
Brief summary
Phase 2a open label, randomised study to evaluate the pharmacokinetics and safety of MicroCor hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in healthy postmenopausal volunteers
Interventions
Part A
Treatment A: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 16 mcg single day application, consecutive day cross over
Treatment B: MicroCor Registered Trademark hPTH(1-34)
TDS 38 mcg single day application, consecutive day cross over
Treatment C: Forteo Registered Trademark teriparatide (rDNA origin) 20 mcg; single subcutaneous injection
Treatment E: MicroCor Registered Trademark hPTH(1-34) Transdermal System model 2 (TDS) 38 mcg single day application, consecutive day
Part A Treatment A: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 16 mcg single day application, consecutive day cross over Treatment B: MicroCor Registered Trademark hPTH(1-34) TDS 38 mcg single day application, consecutive day cross over Treatment C: Forteo Registered Trademark teriparatide (rDNA origin) 20 mcg; single subcutaneous injection Treatment E: MicroCor Registered Trademark hPTH(1-34) Transdermal System model 2 (TDS) 38 mcg single day application, consecutive day cross over. Proprietary internal mechanical design differs between TDS and TDS Model 2. Part B Treatment B: MicroCor Registered Trademark hPTH(1-34) Transdermal System (TDS) 38 mcg daily application for 28 days Treatment C: Forteo Registered Trademark teriparatide (rDNA origin) 20 mcg subcutaneous injection daily for 28 days. Treatment B subjects will have Treatment D MicroCor Registered Trademark placebo Transdermal System (TDS) applied concurrently twice over the 28 days. Part A participants will not be recruited into Part B. Subjects will complete a daily dosing diary that will be reviewed by the study staff to monitor adherence.
Sponsors
Corium International, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: Post-menopausal woman, aged 50-85 years old at screening in otherwise good general health as determined by the Investigator. Agrees to being evaluated for baseline T scores or providing DXA results that are less than 1 year old or subject is willing to undergo a DXA scan at the time of screening. Must have no clinically significant findings as determined by the Investigator based on physical examination, 12-lead ECG and vital signs Clinical laboratory values at screening, including ionized and total calcium, phosphorus, creatinine, albumin, and PTH, must be within the normal limits as defined by the clinical laboratory, or are not clinically significant. Corrected calcium (total calcium normalized) or albumin concentrations must be < upper limit of normal in ref range at the screening visit. 25-hydroxyvitamin D must be >20 ng/ml at the screening visit.
Exclusion criteria
Exclusion: Has a diagnosis of osteoporosis, defined by bone mineral densitometry T score at any location on the body. Had a loss of height greater than 5cm (2 inches) supported by medical records or subject self report. Had recent bone fractures or fragility fractures. Has an uncontrolled medical condition in the opinion of the Investigator or a controlled medical condition requiring regular treatment with prescription drugs that would influence calcium, bone metabolism or relevant biomarkers. Has history of significant chronic disease, cancer or any medical condition known to affect bone metabolism, hepatic or renal disorder requiring medical intervention. Prior use of PTH replacement therapy or any of its analogs within the previous year. Current use and/or use within the last year of corticosteroids (eye drops and topical creams are acceptable). Currently use agents that influence calcium, bone metabolism or relevant biomarkers, such as calcitonins, bisphosphonates, Selective Estrogen Receptor Modulators (SERMs), teriparatide, phenobarbital, phenytoin, glucocorticoids or anabolic steroid agents. Exceptions are: prior bisphosphate therapy if commenced one year prior to randomization, stable doses of Vitamin D and calcium supplements for at least three months prior to screening and PRN (as needed) use of anti-nausea medication.
Outcome results
None listed