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NCT01514500 Clinical Trial

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Healthy Clinical Trial

Official title:
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01514500
Other study ID # NN8640-3915
Secondary ID U1111-1119-05392
Status Completed
Phase Phase 1
First received
Last updated
Start date January 16, 2012
Est. completion date March 18, 2013

Study information
Verified date December 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date March 18, 2013
Est. primary completion date March 18, 2013
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• somapacitan
Administered s.c. (subcutaneously, under the skin)
• placebo (somapacitan)
Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Neuss

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Juul Kildemoes R, Højby Rasmussen M, Agersø H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2020 Dec 12. pii: dgaa775. doi: 10.1210/clinem/dgaa775. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (Single Dose) From first administration of trial product and up until day 40
Primary Incidence of adverse events (Multiple Dose) From first administration of trial product and up until day 49
Secondary Area under the NNC0195-0092 (somapacitan) serum concentration-time curve From 0 to 168 hours
Secondary Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) From 0-240 hours
Secondary Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) up to day 40
Secondary Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) up to day 40
Secondary Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve From 0-168 hours
Secondary Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) From 0-240 hours
Secondary Maximum serum concentration (Cmax) for IGF-I up to day 40
Secondary Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve From 0-168 hours
Secondary Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) From 0-240 hours
Secondary Maximum serum concentration (Cmax) for IGFBP-3 up to day 40
Secondary Number of injection site reactions From first administration of trial product and up until day 40 (SD part)
Secondary Number of injection site reactions From first administration of trial product and up until day 49 (MD part)
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