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Completed

NCT Number: NCT03212131

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics).

In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged 18-75 years (both inclusive)
  • Body mass index of 18.5-39.9 kg/sqm (both inclusive)
  • Subjects with normal hepatic function or hepatic impairment (mild or moderate)

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) for at least 16 days after the last trial product administration
  • 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 blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
  • Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol

Treatment and study plan

Somapacitan

Drug

3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg

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 somapacitan measured in blood

Secondary outcomes

  1. Maximum serum concentration of somapacitan

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

    Calculated based on plasma somapacitan activity measured in blood

  2. Time to maximum serum concentration of somapacitan

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

    Calculated based on plasma somapacitan activity measured in blood

  3. Incidence of adverse events

    Time frame: From first dosing to Day 43

    Count

  4. Occurrence of anti-somapacitan antibodies

    Time frame: From Day 0 to Day 43

    Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2017
Registry last updated
May 24, 2019

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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