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

Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936984
• Other study ID #: BA058-05-023
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2020
• Est. completion date: August 13, 2021

Study information

• Verified date: June 2021
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 13, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Combination Product:
• abaloparatide-sMTS (Patheon)
single-dose administration of abaloparatide 300 µg applied to the thigh for 5 minutes
• abaloparatide-sMTS (Kindeva)
single-dose administration of abaloparatide 300 µg applied to the thigh for 5 minutes
• abaloparatide-sMTS (Patheon)
single-dose administration of abaloparatide 300 µg applied to the thigh for 4 minutes
• abaloparatide-sMTS (Patheon)
single-dose administration of abaloparatide 300 µg applied to the thigh for 7 minutes

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Radius Health, Inc.	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		4 single-dose administrations, separated by 48 hours.
Primary	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.
Primary	AUC from time 0 extrapolated to time infinity (AUC 0-8)		4 single-dose administrations, separated by 48 hours.
Secondary	Subjects with treatment-emergent AEs and SAEs		14 ± 2 days