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

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.

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Combination product: abaloparatide-sMTS (Patheon); Combination product: abaloparatide-sMTS (Kindeva); Combination product: abaloparatide-sMTS (Patheon); Combination product: abaloparatide-sMTS (Patheon)

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

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; 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); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Kindeva); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes; Other Names: abaloparatide-sMTS
EXPERIMENTAL: Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min; 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); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Kindeva); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes; Other Names: abaloparatide-sMTS
EXPERIMENTAL: Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min; 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); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Kindeva); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes; Other Names: abaloparatide-sMTS
EXPERIMENTAL: Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min; 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); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Kindeva); single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes; Other Names: abaloparatide-sMTS; Combination product: abaloparatide-sMTS (Patheon); single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes; Other Names: abaloparatide-sMTS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Radius Health, Inc.
• Collaborators: Medpace, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ACTUAL): February 9, 2021
• Study Completion (ACTUAL): August 13, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (ACTUAL): June 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PK; osteoporosis; transdermal delivery; microneedle patch; abaloparatide-SC; solid microstructured transdermal system; abaloparatide TYMLOS®
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Parathyroid Hormone-Related Protein; Abaloparatide
• Other Study ID Numbers: BA058-05-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes