Skip to main content
OpenTrials
Completed

NCT Number: NCT01514500

First Human Dose Trial of NNC0195-0092 (Somapacitan) 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 (somapacitan) compared to placebo in healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Hormone Deficiency in Children Healthy Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somapacitan

Drug

Administered s.c. (subcutaneously, under the skin)

Other names: NNC0195-0092

placebo (somapacitan)

Drug

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Primary outcomes

  1. Incidence of adverse events (Single Dose)

    Time frame: From first administration of trial product and up until day 40

  2. Incidence of adverse events (Multiple Dose)

    Time frame: From first administration of trial product and up until day 49

Secondary outcomes

  1. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve

    Time frame: From 0 to 168 hours

  2. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)

    Time frame: From 0-240 hours

  3. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)

    Time frame: up to day 40

  4. Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)

    Time frame: up to day 40

  5. Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve

    Time frame: From 0-168 hours

  6. Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)

    Time frame: From 0-240 hours

  7. Maximum serum concentration (Cmax) for IGF-I

    Time frame: up to day 40

  8. Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve

    Time frame: From 0-168 hours

  9. 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

  10. Maximum serum concentration (Cmax) for IGFBP-3

    Time frame: up to day 40

  11. Number of injection site reactions

    Time frame: From first administration of trial product and up until day 40 (SD part)

  12. Number of injection site reactions

    Time frame: From first administration of trial product and up until day 49 (MD part)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2012
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.