Growth Hormone DisorderPhase 1NCT01514500
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
A Phase 1 study testing somapacitan in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
- What is being tested?
- somapacitan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2012to 18 Mar 2013
- Phase
- Phase 1
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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy, non-smoking male subjects
- BMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl.
- Body weight 50 to 100 kg, both incl.
Who cannot join
- Strenuous exercise within 4 days prior to dosing
- Receipt of any investigational medicinal product within 3 months prior to randomisation
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.
- Conditions
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Healthy
- Being tested
- somapacitan, placebo (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
Also called NNC0195-0092
Administered s.c. (subcutaneously, under the skin)
placebo (somapacitan)Drug
Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Single dose (SD) | Experimental | Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation Receives: Drug: somapacitan; Drug: placebo (somapacitan) |
| Multiple dose (MD) | Experimental | Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation Receives: Drug: somapacitan; Drug: placebo (somapacitan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (Single Dose)
Measured: From first administration of trial product and up until day 40
Incidence of adverse events (Multiple Dose)
Measured: From first administration of trial product and up until day 49
Secondary outcomes (12)
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve
Measured: From 0 to 168 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Measured: From 0-240 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Measured: up to day 40
Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)
Measured: up to day 40
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve
Measured: From 0-168 hours
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)
Measured: From 0-240 hours
Maximum serum concentration (Cmax) for IGF-I
Measured: up to day 40
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve
Measured: From 0-168 hours
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)
Measured: From 0-240 hours
Maximum serum concentration (Cmax) for IGFBP-3
Measured: up to day 40
Number of injection site reactions
Measured: From first administration of trial product and up until day 40 (SD part)
Number of injection site reactions
Measured: From first administration of trial product and up until day 49 (MD part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start16 Jan 2012
- Primary completion18 Mar 2013
- Study completion18 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 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
- NCT01514500
- Sponsor's protocol ID
- NN8640-3915
- Other IDs
- U1111-1119-0539, 2011-000146-38
- Status last verified
- Dec 2020
- First submitted
- 13 Jan 2012
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
PubMed 33313798Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
PubMed 29671202Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11.
PubMed 25013997