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First Human Dose Trial of NNC0195-0092 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01514500
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 compared to placebo in healthy male subjects.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: First Human Dose Trial of NNC0195-0092 in Healthy Subjects
Actual Study Start Date : January 16, 2012
Primary Completion Date : March 18, 2013
Study Completion Date : March 18, 2013


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Area under the NNC0195-0092 serum concentration-time curve [ Time Frame: From 0 to 168 hours ]
  2. Area under the NNC0195-0092 serum concentration-time curve (SD part only) [ Time Frame: From 0-240 hours ]
  3. Area under the NNC0195-0092 serum concentration-time curve (SD part only) [ Time Frame: up to day 40 ]
  4. Maximum serum concentration (Cmax) for NNC0195-0092 [ 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514500


Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01514500     History of Changes
Other Study ID Numbers: NN8640-3915
U1111-1119-0539 ( Other Identifier: WHO )
2011-000146-38 ( EudraCT Number )
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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