NCT01514500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2013

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

January 13, 2012

Last Update Submit

December 22, 2020

Conditions

Growth Hormone DisorderAdult Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenHealthy

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (Single Dose)

    From first administration of trial product and up until day 40

  • Incidence of adverse events (Multiple Dose)

    From first administration of trial product and up until day 49

Secondary Outcomes (12)

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

    From 0 to 168 hours

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

    From 0-240 hours

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

    up to day 40

  • Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)

    up to day 40

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

    From 0-168 hours

  • +7 more secondary outcomes

Study Arms (2)

Single dose (SD)

EXPERIMENTAL

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

Drug: somapacitanDrug: placebo (somapacitan)

Multiple dose (MD)

EXPERIMENTAL

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: somapacitanDrug: placebo (somapacitan)

Interventions

somapacitanDRUG

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

Also known as: NNC0195-0092
Multiple dose (MD)Single dose (SD)
placebo (somapacitan)DRUG

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

Multiple dose (MD)Single dose (SD)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Strenuous exercise within 4 days prior to dosing
  • Receipt of any investigational medicinal product within 3 months prior to randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (3)

  • 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.

    PMID: 33313798BACKGROUND

  • 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.

    PMID: 29671202DERIVED

  • 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.

    PMID: 25013997DERIVED

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitanNNC0195-0092

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 23, 2012

Study Start

January 16, 2012

Primary Completion

March 18, 2013

Study Completion

March 18, 2013

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

DE(1)