Healthy VolunteersPhase 1NCT04663464
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
A Phase 1 study testing abaloparatide-sMTS and abaloparatide-SC in people with Healthy Volunteers, run by Radius Health, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- abaloparatide-sMTS and abaloparatide-SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 19 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
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
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- abaloparatide-sMTS, abaloparatide-SC
- Keywords
- osteoporosis, transdermal delivery, solid microstructured transdermal system, abaloparatide, TYMLOS®, abaloparatide-SC, abaloparatide-sMTS, PK
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abaloparatide-sMTSCombination product
Also called BA058; abaloparatide-sMTS
Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
abaloparatide-SCCombination product
Also called BA058; abaloparatide-SC
Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: abaloparatide-sMTS; Combination Product: abaloparatide-SC |
| Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2) | Experimental | Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2). Receives: Combination Product: abaloparatide-sMTS; Combination Product: abaloparatide-SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Cmax
Maximum observed concentration (Cmax)
Measured: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
PK AUC1
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Measured: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
PK AUC2
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Measured: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Secondary outcomes (1)
Subjects with AEs and SAEs
Subjects with treatment-emergent AEs and SAEs.
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start16 Nov 2020
- Primary completion27 Mar 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663464
- Sponsor's protocol ID
- BA058-05-024
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT04663464
- Acronym / sponsor ID
- BA058-05-024
- Conditions
- Healthy Volunteers
- Keywords
- osteoporosis, transdermal delivery, solid microstructured transdermal system, abaloparatide, TYMLOS®, abaloparatide-SC, abaloparatide-sMTS, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) | Experimental | Combination Product: abaloparatide-sMTS, Combination Product: abaloparatide-SCAbaloparatide-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 | Combination Product: abaloparatide-sMTS, Combination Product: abaloparatide-SCAbaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abaloparatide-sMTSAlso: BA058; abaloparatide-sMTSSingle-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes | Combination product | Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2), abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) |
| abaloparatide-SCAlso: BA058; abaloparatide-SCSingle-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen | Combination product | Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2), abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) |
Primary outcome
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-∞)
1 secondary outcome
Subjects with AEs and SAEs
Time frame: 10 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing abaloparatide-sMTS and abaloparatide-SC in people with Healthy Volunteers, run by Radius Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Cmax (time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.