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

Sponsor

Radius Health, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04663464

Collaborator

Medpace, Inc. (Industry)

Enrollment

Location

Arms

12.1

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Combination Product: abaloparatide-sMTS Combination Product: abaloparatide-SC	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2020

Actual Primary Completion Date :

Mar 27, 2021

Actual Study Completion Date :

Nov 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide.	Combination Product: abaloparatide-sMTS Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes Other Names: BA058; abaloparatide-sMTS Combination Product: abaloparatide-SC Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen Other Names: BA058; abaloparatide-SC
Experimental: Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2) Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).	Combination Product: abaloparatide-sMTS Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes Other Names: BA058; abaloparatide-sMTS Combination Product: abaloparatide-SC Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen Other Names: BA058; abaloparatide-SC

Arm

Intervention/Treatment

Experimental: abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)

Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide.

Combination Product: abaloparatide-sMTS

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

Other Names:

BA058; abaloparatide-sMTS

Combination Product: abaloparatide-SC

Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen

Other Names:

BA058; abaloparatide-SC

Experimental: Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)

Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).

Combination Product: abaloparatide-sMTS

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

Other Names:

BA058; abaloparatide-sMTS

Combination Product: abaloparatide-SC

Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen

Other Names:

BA058; abaloparatide-SC

Outcome Measures

Primary Outcome Measures

PK Cmax [Time frame for collection of PK data after each single-dose administration, separated by 48 hours]
Maximum observed concentration (Cmax)
PK AUC1 [Time frame for collection of PK data after each single-dose administration, 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)
PK AUC2 [Time frame for collection of PK data after each single-dose administration, separated by 48 hours]
AUC from time 0 extrapolated to time infinity (AUC 0-∞)

Secondary Outcome Measures

Subjects with AEs and SAEs [10 Days]
Subjects with treatment-emergent AEs and SAEs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;.