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

NCT04663464 | Completed Phase 1 FDA Drug

• 1 other identifier: BA058-05-024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Keywords

osteoporosis; transdermal delivery; solid microstructured transdermal system; abaloparatide; TYMLOS®; abaloparatide-SC; abaloparatide-sMTS; PK

Outcome Measures

Primary Outcomes (3)

• PK Cmax

  Maximum observed concentration (Cmax)

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

Secondary Outcomes (1)

• Subjects with AEs and SAEs

  10 Days

Study Arms (2)

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

EXPERIMENTAL

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; Combination Product: abaloparatide-SC

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

EXPERIMENTAL

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

Combination Product: abaloparatide-sMTS; Combination Product: abaloparatide-SC

Interventions

abaloparatide-sMTS COMBINATION_PRODUCT

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

Also known as: BA058; abaloparatide-sMTS

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

abaloparatide-SC COMBINATION_PRODUCT

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

Also known as: BA058; abaloparatide-SC

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;.

Sponsors & Collaborators

• Radius Health, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: November 16, 2020
• Primary Completion: March 27, 2021
• Study Completion: November 19, 2021
• Last Updated: January 6, 2022

Record last verified: 2020-12

Locations

US (1)