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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
abaloparatide-sMTS (Patheon)
abaloparatide-sMTS (Kindeva)
abaloparatide-sMTS (Patheon)
abaloparatide-sMTS (Patheon)
Sponsored by
Radius Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, transdermal delivery, microneedle patch, solid microstructured transdermal system, abaloparatide TYMLOS®, abaloparatide-SC, PK

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • Medpace Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min

Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min

Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min

Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax)
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
AUC from time 0 extrapolated to time infinity (AUC 0-∞)

Secondary Outcome Measures

Subjects with treatment-emergent AEs and SAEs

Full Information

First Posted
June 16, 2021
Last Updated
January 5, 2022
Sponsor
Radius Health, Inc.
Collaborators
Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04936984
Brief Title
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Health, Inc.
Collaborators
Medpace, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, transdermal delivery, microneedle patch, solid microstructured transdermal system, abaloparatide TYMLOS®, abaloparatide-SC, PK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min
Arm Type
Experimental
Arm Description
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).
Arm Title
Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min
Arm Type
Experimental
Arm Description
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).
Arm Title
Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min
Arm Type
Experimental
Arm Description
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).
Arm Title
Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min
Arm Type
Experimental
Arm Description
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).
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide-sMTS (Patheon)
Other Intervention Name(s)
abaloparatide-sMTS
Intervention Description
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide-sMTS (Kindeva)
Other Intervention Name(s)
abaloparatide-sMTS
Intervention Description
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide-sMTS (Patheon)
Other Intervention Name(s)
abaloparatide-sMTS
Intervention Description
single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes
Intervention Type
Combination Product
Intervention Name(s)
abaloparatide-sMTS (Patheon)
Other Intervention Name(s)
abaloparatide-sMTS
Intervention Description
single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Time Frame
4 single-dose administrations, separated by 48 hours.
Title
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Time Frame
4 single-dose administrations, separated by 48 hours.
Title
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Time Frame
4 single-dose administrations, separated by 48 hours.
Secondary Outcome Measure Information:
Title
Subjects with treatment-emergent AEs and SAEs
Time Frame
14 ± 2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Medpace Clinical Pharmacology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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