Status:
COMPLETED
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Lead Sponsor:
Radius Health, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief Summary
A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women
Detailed Description
This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and 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 32 kg/m\^2;
- Laboratory test results 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;.
Exclusion
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04663464
Start Date
November 16 2020
End Date
November 19 2021
Last Update
January 6 2022
Active Locations (1)
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1
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States, 45227