First Human Dose Trial of NNC0195-0092 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01514500
First received: January 13, 2012
Last updated: April 11, 2013
Last verified: April 2013

January 13, 2012
April 11, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
  • Incidence of adverse events (Single Dose) [ Time Frame: From first administration of trial product and up until day 40 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (Multiple Dose) [ Time Frame: From first administration of trial product and up until day 49 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514500 on ClinicalTrials.gov Archive Site
  • Area under the NNC0195-0092 serum concentration-time curve [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
  • Area under the NNC0195-0092 serum concentration-time curve (SD part only) [ Time Frame: From 0-240 hours ] [ Designated as safety issue: No ]
  • Area under the NNC0195-0092 serum concentration-time curve (SD part only) [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) for NNC0195-0092 [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve [ Time Frame: From 0-168 hours ] [ Designated as safety issue: No ]
  • Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) [ Time Frame: From 0-240 hours ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) for IGF-I [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve [ Time Frame: From 0-168 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) for IGFBP-3 [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Number of injection site reactions [ Time Frame: From first administration of trial product and up until day 40 (SD part) ] [ Designated as safety issue: No ]
  • Number of injection site reactions [ Time Frame: From first administration of trial product and up until day 49 (MD part) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
First Human Dose Trial of NNC0195-0092 in Healthy Subjects
First Human Dose Trial of NNC0195-0092 in Healthy Subjects

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 compared to placebo in healthy male subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Growth Hormone Deficiency in Children
  • Healthy
  • Drug: NNC0195-0092
    Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
  • Drug: placebo
    Single placebo dose administered s.c. (subcutaneously, under the skin)
  • Drug: NNC0195-0092
    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
  • Drug: placebo
    Multiple placebo doses administered s.c. (subcutaneously, under the skin)
  • Experimental: Single dose (SD)
    Interventions:
    • Drug: NNC0195-0092
    • Drug: placebo
  • Experimental: Multiple dose (MD)
    Interventions:
    • Drug: NNC0195-0092
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01514500
NN8640-3915, U1111-1119-0539, 2011-000146-38
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Minna Brændholt Olsen Novo Nordisk A/S
Novo Nordisk A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP