Healthy VolunteersPhase 1NCT03905850
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
A Phase 1 study testing somapacitan in people with Healthy Volunteers and Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Growth Hormone Deficiency
- What is being tested?
- somapacitan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2019to 15 Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18-45 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.5 and 24.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening.
- Body weight above 100.0 kg
- Subject with any known history of growth hormone deficiency as declared by the subject.
- Subject who is non-naïve to growth hormone treatment as declared by the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL
This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Healthy Volunteers, Growth Hormone Deficiency
- Being tested
- somapacitan
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somapacitanDrug
5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Somapacitan 5/10/10 mg | Experimental | One dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period. Receives: Drug: somapacitan |
| Somapacitan 10/5/10 mg | Experimental | One dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. Receives: Drug: somapacitan |
| Somapacitan 10/10/5 mg | Experimental | Two doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. Receives: Drug: somapacitan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
ng*h/mL
Measured: 0 to 504 hours after trial product administration
Maximum serum concentration of somapacitan
ng/mL
Measured: 0 to 504 hours after trial product administration
Secondary outcomes (7)
Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
ng*h/mL
Measured: 0 to 168 hours after trial product administration
Area under the somapacitan serum concentration time curve from time 0 to infinity
ng*h/mL
Measured: 0 to 504 hours after trial product administration
Time to maximum serum concentration of somapacitan
Hours
Measured: 0 to 504 hours after trial product administration
Terminal half-life of somapacitan
Hours
Measured: 0 to 504 hours after trial product administration
Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing
ng*h/mL
Measured: 0 to 168 hours after trial product administration
Maximum serum concentration of IGF-I after dosing
ng/mL
Measured: 0 to 504 hours after trial product administration
Time to maximum serum concentration of IGF-I after dosing
Hours
Measured: 0 to 504 hours after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start29 Mar 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905850
- Sponsor's protocol ID
- NN8640-4491
- Other IDs
- 2018-003670-27, U1111-1220-5197, 2018
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Dombernowsky SL, Damholt BB, Hojby Rasmussen M, Svaerke C, Kildemoes RJ. Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial. Clin Pharmacokinet. 2024 Jul;63(7):1015-1024. doi: 10.1007/s40262-024-01395-y. Epub 2024 Jul 5.
PubMed 38969919
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL
- ClinicalTrials.gov ID
- NCT03905850
- Acronym / sponsor ID
- NN8640-4491
- Conditions
- Healthy Volunteers, Growth Hormone Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 5 Apr 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 study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Somapacitan 5/10/10 mg | Experimental | Drug: somapacitanOne dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period. |
| Somapacitan 10/5/10 mg | Experimental | Drug: somapacitanOne dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
| Somapacitan 10/10/5 mg | Experimental | Drug: somapacitanTwo doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-45 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 18.5 and 24.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (4 listed)
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening.
- Body weight above 100.0 kg
- Subject with any known history of growth hormone deficiency as declared by the subject.
- Subject who is non-naïve to growth hormone treatment as declared by the subject.
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 |
|---|---|---|
| somapacitan5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin) | Drug | Somapacitan 10/10/5 mg, Somapacitan 10/5/10 mg, Somapacitan 5/10/10 mg |
Primary outcome
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
Time frame: 0 to 504 hours after trial product administration
ng*h/mL
Maximum serum concentration of somapacitan
Time frame: 0 to 504 hours after trial product administration
ng/mL
7 secondary outcomes
Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
Time frame: 0 to 168 hours after trial product administration
Area under the somapacitan serum concentration time curve from time 0 to infinity
Time frame: 0 to 504 hours after trial product administration
Time to maximum serum concentration of somapacitan
Time frame: 0 to 504 hours after trial product administration
Terminal half-life of somapacitan
Time frame: 0 to 504 hours after trial product administration
Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing
Time frame: 0 to 168 hours after trial product administration
Maximum serum concentration of IGF-I after dosing
Time frame: 0 to 504 hours after trial product administration
Time to maximum serum concentration of IGF-I after dosing
Time frame: 0 to 504 hours after trial product administration
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 Aug 2019.
- Derived from this study: PubMed 38969919Dombernowsky SL, Damholt BB, Hojby Rasmussen M, Svaerke C, Kildemoes RJ. Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial. Clin Pharmacokinet. 2024 Jul;63(7):1015-1024. doi: 10.1007/s40262-024-01395-y. Epub 2024 Jul 5.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
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 somapacitan in people with Healthy Volunteers and Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
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 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 Aug 2019. 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 Germany. 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 somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing (time frame: 0 to 504 hours after trial product administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905850, which also lists 1 linked publication.
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 Aug 2019.