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

Primary Purpose

Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
somapacitan
placebo (somapacitan)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Disorder

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single dose (SD)

Multiple dose (MD)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse events (Single Dose)
Incidence of adverse events (Multiple Dose)

Secondary Outcome Measures

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)
Maximum serum concentration (Cmax) for IGF-I
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)
Maximum serum concentration (Cmax) for IGFBP-3
Number of injection site reactions
Number of injection site reactions

Full Information

First Posted
January 13, 2012
Last Updated
December 22, 2020
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01514500
Brief Title
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Official Title
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2012 (Actual)
Primary Completion Date
March 18, 2013 (Actual)
Study Completion Date
March 18, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose (SD)
Arm Type
Experimental
Arm Description
Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
Arm Title
Multiple dose (MD)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
somapacitan
Other Intervention Name(s)
NNC0195-0092
Intervention Description
Administered s.c. (subcutaneously, under the skin)
Intervention Type
Drug
Intervention Name(s)
placebo (somapacitan)
Intervention Description
Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
Primary Outcome Measure Information:
Title
Incidence of adverse events (Single Dose)
Time Frame
From first administration of trial product and up until day 40
Title
Incidence of adverse events (Multiple Dose)
Time Frame
From first administration of trial product and up until day 49
Secondary Outcome Measure Information:
Title
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve
Time Frame
From 0 to 168 hours
Title
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Time Frame
From 0-240 hours
Title
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)
Time Frame
up to day 40
Title
Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)
Time Frame
up to day 40
Title
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve
Time Frame
From 0-168 hours
Title
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)
Time Frame
From 0-240 hours
Title
Maximum serum concentration (Cmax) for IGF-I
Time Frame
up to day 40
Title
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve
Time Frame
From 0-168 hours
Title
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
Title
Maximum serum concentration (Cmax) for IGFBP-3
Time Frame
up to day 40
Title
Number of injection site reactions
Time Frame
From first administration of trial product and up until day 40 (SD part)
Title
Number of injection site reactions
Time Frame
From first administration of trial product and up until day 49 (MD part)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR,1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33313798
Citation
Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
Results Reference
background
PubMed Identifier
29671202
Citation
Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
Results Reference
derived
PubMed Identifier
25013997
Citation
Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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