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Trial · Interventional

CompletedPhase 1Registry data

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

NCTNCT03186495 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4297Other idU1111-1187-9141Other id2016-003910-29Other id2016

Overview

Status
Completed
Phase
Phase 1
Enrollment
44 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
20 Jun 2017
Primary completion
17 May 2018
Completion
17 May 2018
First posted
14 Jun 2017
Last update posted
17 Apr 2020
Conditions
Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1

    Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

    NCT03186495

    20 Jun 2017 to 17 May 2018

Registry summary

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

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

Interventions

  • SomapacitanDrug

Arms5

  • Experimental

    Normal renal function

    Subjects with normal renal function

  • Experimental

    Mild renal impairment

    Subjects with mild renal impairment

  • Experimental

    Moderate renal impairment

    Subjects with moderate renal impairment

  • Experimental

    Severe renal impairment

    Subjects with severe renal impairment

  • Experimental

    Requiring haemodialysis treatment

    Subjects requiring haemodialysis treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the somapacitan serum concentration time curve

    Time frame · From time 0 to 168 hours after the last dosing on Day 15.

    Registry description

    Calculated based on the serum concentrations measured in ug/l

Secondary outcomes(4)
  1. Maximum serum concentration of somapacitan

    Time frame · After the last dosing on Day 15 up until Day 43

    Registry description

    Measured in ng/ml

  2. Time to maximum serum concentration of somapacitan

    Time frame · After the last dosing on Day 15 up until Day 43

    Registry description

    Calculated based on the serum concentrations measured in ug/l

  3. Incidence of adverse events

    Time frame · Day 0 - 43

    Registry description

    Count and % of events

  4. Occurrence of anti-somapacitan antibodies

    Time frame · Day 0 - 43

    Registry description

    Count or % of events

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

9 results

Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials.

Bentz Damholt et al. 2021Clinical pharmacokineticscited by 4

PMID 33754315PMC8332591DOI 10.1007/s40262-021-00990-7PUB-33754315

Free to read · publisher termsCC BY-NC9 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Body mass index between 18.5-34.9 kg/sqm (both inclusive) * Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration * Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment

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