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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04663464 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-024
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Overview

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

United States

Start
16 Nov 2020
Primary completion
27 Mar 2021
Completion
19 Nov 2021
First posted
11 Dec 2020
Last update posted
6 Jan 2022
Conditions
Healthy Volunteers

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 PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

    NCT04663464

    16 Nov 2020 to 19 Nov 2021

Registry summary

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

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

Interventions

  • abaloparatide-sMTSCombination product
  • abaloparatide-SCCombination product

Arms2

  • Experimental

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

    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.

  • Experimental

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

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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. PK Cmax

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

    Registry description

    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

    Registry description

    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

    Registry description

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

Secondary outcomes(1)

  1. Subjects with AEs and SAEs

    Time frame · 10 Days

    Registry description

    Subjects with treatment-emergent AEs and SAEs.

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

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