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

NCT04936984 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: BA058-05-023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

osteoporosis; transdermal delivery; microneedle patch; solid microstructured transdermal system; abaloparatide TYMLOS®; abaloparatide-SC; PK

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Subjects with treatment-emergent AEs and SAEs

  14 ± 2 days

Study Arms (4)

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

EXPERIMENTAL

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); Combination Product: abaloparatide-sMTS (Kindeva)

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

EXPERIMENTAL

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); Combination Product: abaloparatide-sMTS (Kindeva)

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

EXPERIMENTAL

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); Combination Product: abaloparatide-sMTS (Kindeva)

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

EXPERIMENTAL

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); Combination Product: abaloparatide-sMTS (Kindeva)

Interventions

abaloparatide-sMTS (Patheon) COMBINATION_PRODUCT

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

Also known as: abaloparatide-sMTS

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

abaloparatide-sMTS (Kindeva) COMBINATION_PRODUCT

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

Also known as: abaloparatide-sMTS

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Radius Health, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 23, 2021
• Study Start: November 16, 2020
• Primary Completion: February 9, 2021
• Study Completion: August 13, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)