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
Phase 1
Completed
- Conditions
- Adult Growth Hormone DeficiencyGrowth Hormone DisorderGrowth Hormone Deficiency in Children
- Interventions
- Registration Number
- NCT03186495
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal renal function Somapacitan Subjects with normal renal function Mild renal impairment Somapacitan Subjects with mild renal impairment Moderate renal impairment Somapacitan Subjects with moderate renal impairment Severe renal impairment Somapacitan Subjects with severe renal impairment Requiring haemodialysis treatment Somapacitan Subjects requiring haemodialysis treatment
- Primary Outcome Measures
Name Time Method Area under the somapacitan serum concentration time curve From time 0 to 168 hours after the last dosing on Day 15. Calculated based on the serum concentrations measured in ug/l
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Day 0 - 43 Count and % of events
Maximum serum concentration of somapacitan After the last dosing on Day 15 up until Day 43 Measured in ng/ml
Time to maximum serum concentration of somapacitan After the last dosing on Day 15 up until Day 43 Calculated based on the serum concentrations measured in ug/l
Occurrence of anti-somapacitan antibodies Day 0 - 43 Count or % of events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Berlin, Germany