Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
Phase 1
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT04936984
- Lead Sponsor
- Radius Health, Inc.
- Brief Summary
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
- Detailed Description
This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
- Female subjects aged 40 to 65 years old, inclusive, at Screening
- Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m^2 inclusive)
- Laboratory tests within the normal range
- Serum 25-hydroxyvitamin D values must be > 20 ng/mL
Exclusion Criteria
- Presence or history of any disorder that may prevent the successful completion of the study.
- Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
- History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
- History of allergy to abaloparatide or drugs in a similar pharmacological class;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method AUC from time 0 extrapolated to time infinity (AUC 0-∞) 4 single-dose administrations, separated by 48 hours. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t) 4 single-dose administrations, separated by 48 hours. Maximum observed concentration (Cmax) 4 single-dose administrations, separated by 48 hours.
- Secondary Outcome Measures
Name Time Method Subjects with treatment-emergent AEs and SAEs 14 ± 2 days
Trial Locations
- Locations (1)
Medpace Clinical Pharmacology
🇺🇸Cincinnati, Ohio, United States
Medpace Clinical Pharmacology🇺🇸Cincinnati, Ohio, United States