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First Human Dose Trial of NNC0195-0092 in Healthy Subjects

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

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.


Condition Intervention Phase
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Growth Hormone Deficiency in Children
Healthy
 Drug: NNC0195-0092
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: First Human Dose Trial of NNC0195-0092 in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 105
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose (SD) 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)
Experimental: Multiple dose (MD) 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)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514500

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Minna Brændholt Olsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01514500     History of Changes
Other Study ID Numbers: NN8640-3915, U1111-1119-0539, 2011-000146-38
Study First Received: January 13, 2012
Last Updated: April 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
 Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013