HealthyPhase 1NCT02962440
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
A Phase 1 study testing somapacitan in people with Healthy, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects. Read more about this study
- Who is it for?
- Ages 45 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2016to Jan 2017
- 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 45 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 45-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
- Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
- Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Subcutaneous Dosing in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.
- Conditions
- Healthy
- Being tested
- somapacitan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somapacitanDrug
All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan
| Study group | Role | What they receive |
|---|---|---|
| Somapacitan | Experimental | Not described Receives: Drug: somapacitan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
Measured: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
Measured: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
Measured: Assessed up to 35 days after trial product administration
Secondary outcomes (2)
Total recovery of administered 3H label (sum of urine, faeces and expired air)
Measured: Assessed up to 36 days after trial product administration
Blood to plasma ratio of [3H]-somapacitan related material
Measured: Assessed up to 36 days 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 posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017
- Study completionJan 2017
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 HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962440
- Sponsor's protocol ID
- NN8640-4237
- Other IDs
- 2016-000096-24, U1111-1178-1251, 2016
- Status last verified
- Jun 2017
- First submitted
- 9 Nov 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1.
PubMed 34601071
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Subcutaneous Dosing in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02962440
- Acronym / sponsor ID
- NN8640-4237
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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 trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somapacitan | Experimental | Drug: somapacitan |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, aged 45-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Key exclusion criteria (3 listed)
- Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
- Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
- Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.
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 |
|---|---|---|
| somapacitanAll subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan | Drug | Somapacitan |
Primary outcome
Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
Time frame: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
Time frame: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
Time frame: Assessed up to 35 days after trial product administration
2 secondary outcomes
Total recovery of administered 3H label (sum of urine, faeces and expired air)
Time frame: Assessed up to 36 days after trial product administration
Blood to plasma ratio of [3H]-somapacitan related material
Time frame: Assessed up to 36 days 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 7 Jun 2017.
- Derived from this study: PubMed 34601071Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1.
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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.
Global Clinical Registry (GCR, 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, run by Novo Nordisk A/S at 1 site in Netherlands.
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 3 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 7 Jun 2017. 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 Netherlands. 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?
Total amount of [3H]-somapacitan related material excreted in urine (% of dose) (time frame: Assessed up to 35 days after trial product administration). 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?
On the ClinicalTrials.gov record for NCT02962440, 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 7 Jun 2017.