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

An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04663464

Enrollment

Registered

2020-12-11

Start date

2020-11-16

Completion date

2021-11-19

Last updated

2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

osteoporosis, transdermal delivery, solid microstructured transdermal system, abaloparatide, TYMLOS®, abaloparatide-SC, abaloparatide-sMTS, PK

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.

Interventions

COMBINATION_PRODUCTabaloparatide-sMTS

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

COMBINATION_PRODUCTabaloparatide-SC

Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Yes

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;.

Design outcomes

Primary

Measure	Time frame	Description
PK Cmax	Time frame for collection of PK data after each single-dose administration, separated by 48 hours	Maximum observed concentration (Cmax)
PK AUC1	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 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

Measure	Time frame	Description
Subjects with AEs and SAEs	10 Days	Subjects with treatment-emergent AEs and SAEs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026