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Trial record 2 of 20 for:    abaloparatide

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

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ClinicalTrials.gov Identifier: NCT04663464
Recruitment Status : Active, not recruiting
First Posted : December 11, 2020
Last Update Posted : April 9, 2021
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Radius Health, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2020
First Posted Date  ICMJE December 11, 2020
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE November 16, 2020
Actual Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • PK Cmax [ Time Frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours ]
    Maximum observed concentration (Cmax)
  • 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)
  • 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-∞)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
Subjects with AEs and SAEs [ Time Frame: 10 Days ]
Subjects with treatment-emergent AEs and SAEs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Official Title  ICMJE An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
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
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Combination Product: abaloparatide-sMTS
    Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
    Other Name: BA058; abaloparatide-sMTS
  • Combination Product: abaloparatide-SC
    Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
    Other Name: BA058; abaloparatide-SC
Study Arms  ICMJE
  • 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.
    Interventions:
    • Combination Product: abaloparatide-sMTS
    • Combination Product: abaloparatide-SC
  • Experimental: Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)
    Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).
    Interventions:
    • Combination Product: abaloparatide-sMTS
    • Combination Product: abaloparatide-SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2020)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04663464
Other Study ID Numbers  ICMJE BA058-05-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radius Health, Inc.
Study Sponsor  ICMJE Radius Health, Inc.
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE Not Provided
PRS Account Radius Health, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP