Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.

Conditions
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Osteoporosis

Intervention / Treatment
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* Combination Product: abaloparatide-sMTS (Patheon)
* Combination Product: abaloparatide-sMTS (Kindeva)
* Combination Product: abaloparatide-sMTS (Patheon)
* Combination Product: abaloparatide-sMTS (Patheon)


Participation Criteria
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Eligibility Criteria
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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;

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

Sexes Eligible for Study
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Female

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: All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min<br>Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). | Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Kindeva)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes<br>* Other names: abaloparatide-sMTS;|
| Experimental: Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min<br>Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). | Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Kindeva)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes<br>* Other names: abaloparatide-sMTS;|
| Experimental: Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min<br>Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). | Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Kindeva)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes<br>* Other names: abaloparatide-sMTS;|
| Experimental: Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min<br>Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). | Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Kindeva)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes<br>* Other names: abaloparatide-sMTS;Combination Product: abaloparatide-sMTS (Patheon)<br>* single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes<br>* Other names: abaloparatide-sMTS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | 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. | 
| AUC from time 0 extrapolated to time infinity (AUC 0-∞) |  | 4 single-dose administrations, separated by 48 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects with treatment-emergent AEs and SAEs |  | 14 ± 2 days | 

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