Current partner codePEPTIDESDE
NCT04936984·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

36

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

abaloparatide-sMTS (Patheon)

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

COMBINATION_PRODUCT

abaloparatide-sMTS (Kindeva)

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

COMBINATION_PRODUCT

abaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes

COMBINATION_PRODUCT

abaloparatide-sMTS (Patheon)

single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes

Timeline

From registration to results.

  1. First posted

    Jun 23, 2021

  2. Study start

    Nov 16, 2020

  3. Primary completion

    Feb 9, 2021

  4. Study completion

    Aug 13, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jan 6, 2022

Outcomes

What the study measures.

Primary outcomes

Maximum observed concentration (Cmax)

Time frame · 4 single-dose administrations, 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)

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

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

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

Secondary outcomes

Subjects with treatment-emergent AEs and SAEs

Time frame · 14 ± 2 days

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
65 Years
Sex
FEMALE
Healthy volunteers
Yes

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;

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.