---
title: Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
nct_id: NCT04663464
overall_status: COMPLETED
phase: PHASE1
sponsor: Radius Health, Inc.
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04663464.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04663464"
ct_last_update_post_date: 2022-01-06
last_seen_at: "2026-05-12T07:23:12.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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:** An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women

**NCT ID:** [NCT04663464](https://clinicaltrials.gov/study/NCT04663464)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 52
- **Lead Sponsor:** Radius Health, Inc.
- **Collaborators:** Medpace, Inc.
- **Conditions:** Healthy Volunteers
- **Start Date:** 2020-11-16
- **Completion Date:** 2021-11-19
- **CT.gov Last Update:** 2022-01-06

## 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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;.
```

## Arms

- **abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)** (EXPERIMENTAL) — 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.
- **Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)** (EXPERIMENTAL) — Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).

## Interventions

- **abaloparatide-sMTS** (COMBINATION_PRODUCT) — Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
- **abaloparatide-SC** (COMBINATION_PRODUCT) — Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen

## Primary Outcomes

- **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-∞)

## Secondary Outcomes

- **Subjects with AEs and SAEs** _(time frame: 10 Days)_

## Locations (1)

- Medpace Clinical Pharmacology, Cincinnati, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medpace clinical pharmacology|cincinnati|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04663464.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04663464*  
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