NCT04663464

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	abaloparatide-sMTS	Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
COMBINATION_PRODUCT	abaloparatide-SC	Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen

Timeline

• Start date: 2020-11-16
• Primary completion: 2021-03-27
• Completion: 2021-11-19
• First posted: 2020-12-11
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study