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

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT04663464
• Lead Sponsor: Radius Health, Inc.

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

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 Timeline

• Study Start: 2020-11-16
• Status Verified: 2020-12
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-11
• Primary Completion: 2021-03-27
• Study Completion: 2021-11-19
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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;.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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-∞)
PK Cmax	Time frame for collection of PK data after each single-dose administration, separated by 48 hours	Maximum observed concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Subjects with AEs and SAEs	10 Days	Subjects with treatment-emergent AEs and SAEs.

Trial Locations

Locations (1)

Medpace Clinical Pharmacology; 🇺🇸 Cincinnati, Ohio, United States