DRUG
somapacitan
Administered s.c. (subcutaneously, under the skin)
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Status
Completed
Phase
Phase 1
Enrollment
105
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
placebo (somapacitan)
Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
Timeline
From registration to results.
First posted
Jan 23, 2012
Study start
Jan 16, 2012
Primary completion
Mar 18, 2013
Study completion
Mar 18, 2013
Results posted
Not reported
Registry updated
Dec 24, 2020
Outcomes
What the study measures.
Primary outcomes
Incidence of adverse events (Single Dose)
Time frame · From first administration of trial product and up until day 40
Incidence of adverse events (Multiple Dose)
Time frame · From first administration of trial product and up until day 49
Secondary outcomes
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve
Time frame · From 0 to 168 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Time frame · From 0-240 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Time frame · up to day 40
Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)
Time frame · up to day 40
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve
Time frame · From 0-168 hours
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)
Time frame · From 0-240 hours
Maximum serum concentration (Cmax) for IGF-I
Time frame · up to day 40
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve
Time frame · From 0-168 hours
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)
Time frame · From 0-240 hours
Maximum serum concentration (Cmax) for IGFBP-3
Time frame · up to day 40
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 45 Years
- Sex
- MALE
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Strenuous exercise within 4 days prior to dosing * Receipt of any investigational medicinal product within 3 months prior to randomisation
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Neuss, Germany
Publications
Results and literature.
PMID 33313798 ↗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.PMID 29671202 ↗Juul 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.PMID 25013997 ↗Rasmussen 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.
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Related PeptideStat pages
Put the record in context.
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