Healthy Male VolunteersPhase 1NCT03810664
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
A Phase 1 study testing Somatrogon in people with Healthy Male Volunteers, run by OPKO Health, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Somatrogon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 19 Apr 2019
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18-55 (inclusive) years
- Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
- Non-smoking (by declaration) for a period of at least six months prior to screening visit
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Read the detailed description
The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.
- Conditions
- Healthy Male Volunteers
- Being tested
- Somatrogon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatrogonDrug
A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).
| Study group | Role | What they receive |
|---|---|---|
| Somatrogon pre-filled PEN | Experimental | Not described Receives: Drug: Somatrogon |
| Somatrogon frozen liquid formulation | Active comparator | Not described Receives: Drug: Somatrogon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)
Measured: 30 days
Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)
Measured: 30 days
Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum
Measured: 30 days
Secondary outcomes (5)
AUCt of IGF-1 and IGFBP-3 levels
Measured: 30 days
AUC∞ of IGF-1 and IGFBP-3 levels
Measured: 30 days
Cmax of IGF-1 and IGFBP-3 levels
Measured: 30 days
Time to maximum concentration (Tmax)
Measured: 30 days
Apparent Terminal Rate Constant (λz) and t½
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start18 Jan 2019
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Pagnusset, MD, Principal investigator, QPS Miami Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810664
- Sponsor's protocol ID
- CP-4-011
- Status last verified
- Apr 2020
- First submitted
- 8 Jan 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
- ClinicalTrials.gov ID
- NCT03810664
- Acronym / sponsor ID
- CP-4-011
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 22 Jan 2019 (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.
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Detailed description
The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
| Arm | Type | Receives |
|---|---|---|
| Somatrogon pre-filled PEN | Experimental | Drug: Somatrogon |
| Somatrogon frozen liquid formulation | Active comparator | Drug: Somatrogon |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged 18-55 (inclusive) years
- Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
- Non-smoking (by declaration) for a period of at least six months prior to screening visit
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SomatrogonA single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14). | Drug | Somatrogon frozen liquid formulation, Somatrogon pre-filled PEN |
Primary outcome
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)
Time frame: 30 days
Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)
Time frame: 30 days
Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum
Time frame: 30 days
5 secondary outcomes
AUCt of IGF-1 and IGFBP-3 levels
Time frame: 30 days
AUC∞ of IGF-1 and IGFBP-3 levels
Time frame: 30 days
Cmax of IGF-1 and IGFBP-3 levels
Time frame: 30 days
Time to maximum concentration (Tmax)
Time frame: 30 days
Apparent Terminal Rate Constant (λz) and t½
Time frame: 30 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 28 Apr 2020.
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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.
Sandra Pagnusset, MD principal investigator
QPS Miami Research Associates
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 Somatrogon in people with Healthy Male Volunteers, run by OPKO 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 3 inclusion and 1 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 28 Apr 2020. 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?
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt) (time frame: 30 days). 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 28 Apr 2020.