Clinical trial NCT04936984: Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
Official title: An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: osteoporosis
transdermal delivery
microneedle patch
solid microstructured transdermal system
abaloparatide TYMLOS®
abaloparatide-SC
PK
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2021-06-23
Enrollment: 36
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: 4 single-dose administrations, separated by 48 hours.
measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
timeFrame: 4 single-dose administrations, separated by 48 hours.
measure: AUC from time 0 extrapolated to time infinity (AUC 0-∞)
timeFrame: 4 single-dose administrations, separated by 48 hours.
Secondary outcomes:
measure: Subjects with treatment-emergent AEs and SAEs
timeFrame: 14 ± 2 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
References: