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

Radius Health, Inc.52 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

abaloparatide-sMTSCOMBINATION_PRODUCT

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

abaloparatide-SCCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;.

Locations (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

PK Cmax

Maximum observed concentration (Cmax)

Time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours

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: Time frame for collection of PK data after each single-dose administration, separated by 48 hours

PK AUC2

AUC from time 0 extrapolated to time infinity (AUC 0-∞)

Time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours

Secondary Outcomes

Subjects with AEs and SAEs

Subjects with treatment-emergent AEs and SAEs.

Time frame: 10 Days

Data from ClinicalTrials.gov

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