DRUG
Somapacitan
All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Status
Completed
Phase
Phase 1
Enrollment
44
Locations
1
Results
Not posted
Publications
1
Study summary
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
DRUG
All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Timeline
First posted
Jun 14, 2017
Study start
Jun 20, 2017
Primary completion
May 17, 2018
Study completion
May 17, 2018
Results posted
Not reported
Registry updated
Apr 17, 2020
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 the serum concentrations measured in ug/l
Maximum serum concentration of somapacitan
Time frame · After the last dosing on Day 15 up until Day 43
Measured in ng/ml
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
Incidence of adverse events
Time frame · Day 0 - 43
Count and % of events
Occurrence of anti-somapacitan antibodies
Time frame · Day 0 - 43
Count or % of events
Eligibility
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
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Berlin, Germany
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