Novo Nordisk Investigational Site
Bratislava, 83101, Slovakia
NCT Number: NCT03212131
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Bratislava, 83101, Slovakia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Time frame: From time 0 to 168 hours after the last dosing on Day 15
Calculated based on somapacitan measured in blood
Time frame: After the last dosing on Day 15 until Day 43
Calculated based on plasma somapacitan activity measured in blood
Time frame: After the last dosing on Day 15 until Day 43
Calculated based on plasma somapacitan activity measured in blood
Time frame: From first dosing to Day 43
Count
Time frame: From Day 0 to Day 43
Count
Novo Nordisk A/S
Industry
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
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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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