Clinical trial NCT01514500: First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Official title: First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Growth Hormone Deficiency in Children
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 105
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (Single Dose)
timeFrame: From first administration of trial product and up until day 40
measure: Incidence of adverse events (Multiple Dose)
timeFrame: From first administration of trial product and up until day 49
Secondary outcomes:
measure: Area under the NNC0195-0092 (somapacitan) serum concentration-time curve
timeFrame: From 0 to 168 hours
measure: Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
timeFrame: From 0-240 hours
measure: Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
timeFrame: up to day 40
measure: Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)
timeFrame: up to day 40
measure: Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve
timeFrame: From 0-168 hours
measure: Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)
timeFrame: From 0-240 hours
measure: Maximum serum concentration (Cmax) for IGF-I
timeFrame: up to day 40
measure: Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve
timeFrame: From 0-168 hours
measure: Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)
timeFrame: From 0-240 hours
measure: Maximum serum concentration (Cmax) for IGFBP-3
timeFrame: up to day 40
measure: Number of injection site reactions
timeFrame: From first administration of trial product and up until day 40 (SD part)
measure: Number of injection site reactions
timeFrame: From first administration of trial product and up until day 49 (MD part)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.