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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.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Combination Product: abaloparatide-sMTS Combination Product: abaloparatide-SC Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
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
Official Title: An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
Actual Study Start Date : November 16, 2020
Actual Primary Completion Date : March 27, 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Subjects with AEs and SAEs [ Time Frame: 10 Days ]
    Subjects with treatment-emergent AEs and SAEs.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663464


Locations
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United States, Ohio
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Radius Health, Inc.
Medpace, Inc.
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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT04663464    
Other Study ID Numbers: BA058-05-024
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radius Health, Inc.:
osteoporosis
transdermal delivery
solid microstructured transdermal system
abaloparatide
TYMLOS®
abaloparatide-SC
abaloparatide-sMTS
PK
Additional relevant MeSH terms:
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Abaloparatide
Parathyroid Hormone-Related Protein
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents