Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663464
• Other study ID #: BA058-05-024
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2020
• Est. completion date: November 19, 2021

Study information

• Verified date: December 2020
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women

Description:

This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 19, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria

• Male and 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 32 kg/m^2;

• Laboratory test results 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

• Healthy Volunteers

Intervention

Combination Product:
• abaloparatide-sMTS
Single-dose administration of abaloparatide 300 µg applied to the thigh for 5 minutes
• abaloparatide-SC
Single-dose administration of abaloparatide 80 µg subcutaneous injection to the periumbilical region of the abdomen

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	PK Cmax	Maximum observed concentration (Cmax)	Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Primary	PK AUC1	Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)	Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Primary	PK AUC2	AUC from time 0 extrapolated to time infinity (AUC 0-8)	Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Secondary	Subjects with AEs and SAEs	Subjects with treatment-emergent AEs and SAEs.	10 Days