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

NCT ID: NCT04936984

Last Updated: 2022-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-08-13

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.

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Kindeva)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

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).

Group Type EXPERIMENTAL

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Kindeva)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

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).

Group Type EXPERIMENTAL

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Kindeva)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

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).

Group Type EXPERIMENTAL

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Kindeva)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

abaloparatide-sMTS (Patheon)

Intervention Type COMBINATION_PRODUCT

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

Interventions

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abaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

Intervention Type COMBINATION_PRODUCT

abaloparatide-sMTS (Kindeva)

single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes

Intervention Type COMBINATION_PRODUCT

abaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

Intervention Type COMBINATION_PRODUCT

abaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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abaloparatide-sMTS abaloparatide-sMTS abaloparatide-sMTS abaloparatide-sMTS

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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

Radius Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BA058-05-023

Identifier Type: -

Identifier Source: org_study_id

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