Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

Study Overview
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Brief Summary
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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
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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 applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.

Official Title
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An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Combination Product: abaloparatide-sMTS
* Combination Product: abaloparatide-SC


Participation Criteria
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Eligibility Criteria
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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;.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)<br>Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. | Combination Product: abaloparatide-sMTS<br>* Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: BA058; abaloparatide-sMTS;Combination Product: abaloparatide-SC<br>* Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen<br>* Other names: BA058; abaloparatide-SC;|
| Experimental: Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)<br>Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2). | Combination Product: abaloparatide-sMTS<br>* Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: BA058; abaloparatide-sMTS;Combination Product: abaloparatide-SC<br>* Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen<br>* Other names: BA058; abaloparatide-SC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Cmax | Maximum observed concentration (Cmax) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours | 
| PK AUC1 | Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours | 
| PK AUC2 | AUC from time 0 extrapolated to time infinity (AUC 0-∞) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects with AEs and SAEs | Subjects with treatment-emergent AEs and SAEs. | 10 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, transdermal delivery, solid microstructured transdermal system, abaloparatide, TYMLOS®, abaloparatide-SC, abaloparatide-sMTS, PK