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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04936984 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
36 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
16 Nov 2020
Primary completion
9 Feb 2021
Completion
13 Aug 2021
First posted
23 Jun 2021
Last update posted
6 Jan 2022
Conditions
Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 1

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

    NCT04936984

    16 Nov 2020 to 13 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • abaloparatide-sMTS (Patheon)Combination product
  • abaloparatide-sMTS (Kindeva)Combination product
  • abaloparatide-sMTS (Patheon)Combination product
  • abaloparatide-sMTS (Patheon)Combination product

Arms4

  • Experimental

    Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min

    Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

  • Experimental

    Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min

    Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

  • Experimental

    Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min

    Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

  • Experimental

    Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min

    Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

Primary outcomes3

Outcomes the sponsor listed as primary.

  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)

  1. Subjects with treatment-emergent AEs and SAEs

    Time frame · 14 ± 2 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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;

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