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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01514500
Collaborator
(none)
105
Enrollment
1
Location
2
Arms
14
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

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 (somapacitan) compared to placebo in healthy male subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
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 (Somapacitan) in Healthy Subjects
Actual Study Start Date :
Jan 16, 2012
Actual Primary Completion Date :
Mar 18, 2013
Actual Study Completion Date :
Mar 18, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single dose (SD)

Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation

Drug: somapacitan
Administered s.c. (subcutaneously, under the skin)
Other Names:
  • NNC0195-0092

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

    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: somapacitan
    Administered s.c. (subcutaneously, under the skin)
    Other Names:
  • NNC0195-0092

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (Single Dose) [From first administration of trial product and up until day 40]

    2. Incidence of adverse events (Multiple Dose) [From first administration of trial product and up until day 49]

    Secondary Outcome Measures

    1. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve [From 0 to 168 hours]

    2. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) [From 0-240 hours]

    3. Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) [up to day 40]

    4. Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) [up to day 40]

    5. Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve [From 0-168 hours]

    6. Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) [From 0-240 hours]

    7. Maximum serum concentration (Cmax) for IGF-I [up to day 40]

    8. Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve [From 0-168 hours]

    9. Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) [From 0-240 hours]

    10. Maximum serum concentration (Cmax) for IGFBP-3 [up to day 40]

    11. Number of injection site reactions [From first administration of trial product and up until day 40 (SD part)]

    12. Number of injection site reactions [From first administration of trial product and up until day 49 (MD part)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01514500
    Other Study ID Numbers:
    • NN8640-3915
    • U1111-1119-0539
    • 2011-000146-38
    First Posted:
    Jan 23, 2012
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Dwarfism, Pituitary
    Endocrine System Diseases

    Study Results

    No Results Posted as of Dec 24, 2020