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OpenTrials
Completed

NCT Number: NCT04936984

Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

About this study

This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 34 kg/m^2 inclusive)
  • Laboratory tests 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 (Patheon)

Combination Product

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

Other names: abaloparatide-sMTS

abaloparatide-sMTS (Kindeva)

Combination Product

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

Other names: abaloparatide-sMTS

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: 4 single-dose administrations, separated by 48 hours.

  2. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)

    Time frame: 4 single-dose administrations, separated by 48 hours.

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

    Time frame: 4 single-dose administrations, separated by 48 hours.

Secondary outcomes

  1. Subjects with treatment-emergent AEs and SAEs

    Time frame: 14 ± 2 days

Sponsors and collaborators

Lead sponsor

Radius Health, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2021
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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