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OpenTrials
Completed

NCT Number: NCT03186495

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somapacitan

Drug

All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan

Primary outcomes

  1. Area under the somapacitan serum concentration time curve

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

    Calculated based on the serum concentrations measured in ug/l

Secondary outcomes

  1. Maximum serum concentration of somapacitan

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

    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

    Calculated based on the serum concentrations measured in ug/l

  3. Incidence of adverse events

    Time frame: Day 0 - 43

    Count and % of events

  4. Occurrence of anti-somapacitan antibodies

    Time frame: Day 0 - 43

    Count or % of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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