DRUG
Somapacitan
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Status
Completed
Phase
Phase 1
Enrollment
34
Locations
1
Results
Not posted
Publications
1
Study summary
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.
Interventions
DRUG
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Timeline
First posted
Jul 11, 2017
Study start
Aug 16, 2017
Primary completion
Mar 8, 2018
Study completion
Mar 8, 2018
Results posted
Not reported
Registry updated
May 24, 2019
Outcomes
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
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
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
Incidence of adverse events
Time frame · From first dosing to Day 43
Count
Occurrence of anti-somapacitan antibodies
Time frame · From Day 0 to Day 43
Count
Eligibility
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
Study locations
Slovakia. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Bratislava, Slovakia
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