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OpenTrials
Completed

NCT Number: NCT04663464

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

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;.

Treatment and study plan

abaloparatide-sMTS

Combination Product

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

Other names: BA058; abaloparatide-sMTS

abaloparatide-SC

Combination Product

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

Other names: BA058; abaloparatide-SC

Primary outcomes

  1. PK Cmax

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

    Maximum observed concentration (Cmax)

  2. PK AUC1

    Time frame: 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)

  3. PK AUC2

    Time frame: 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 outcomes

  1. Subjects with AEs and SAEs

    Time frame: 10 Days

    Subjects with treatment-emergent AEs and SAEs.

Sponsors and collaborators

Lead sponsor

Radius Health, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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