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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01514500 (opens ClinicalTrials.gov in a new tab)Other idNN8640-3915Other idU1111-1119-0539Other id2011-000146-38
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
105 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Germany

Start
16 Jan 2012
Primary completion
18 Mar 2013
Completion
18 Mar 2013
First posted
23 Jan 2012 (estimated)
Last update posted
24 Dec 2020
Conditions
Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 1

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

    NCT01514500

    16 Jan 2012 to 18 Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somapacitanDrug
  • placebo (somapacitan)Drug

Arms2

  • 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

  • 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

Primary outcomes2

Outcomes the sponsor listed as primary.

  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 outcomes(12)

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

    Time frame · From 0 to 168 hours

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

    Time frame · From 0-240 hours

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

    Time frame · up to day 40

  4. Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2019

Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials.

Juul et al. 2019Clinical pharmacokineticscited by 29

PMID 29671202PMC6325982DOI 10.1007/s40262-018-0662-5PUB-29671202

Free to read · publisher termsCC BY-NC
Read at source

More studies

1 study on this page

PubMed tag: none · 2021

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.

Juul Kildemoes et al. 2021The Journal of clinical endocrinology and metabolismcited by 30

PMID 33313798PMC7823237DOI 10.1210/clinem/dgaa775PUB-33313798

CC BY
Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedRasmussen 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 25013997

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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