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

Adult Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186495
• Other study ID #: NN8640-4297
• Secondary ID: U1111-1187-91412
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2017
• Est. completion date: May 17, 2018

Study information

• Verified date: April 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder
• Renal Insufficiency

Intervention

Drug:
• Somapacitan
All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the somapacitan serum concentration time curve	Calculated based on the serum concentrations measured in ug/l	From time 0 to 168 hours after the last dosing on Day 15.
Secondary	Maximum serum concentration of somapacitan	Measured in ng/ml	After the last dosing on Day 15 up until Day 43
Secondary	Time to maximum serum concentration of somapacitan	Calculated based on the serum concentrations measured in ug/l	After the last dosing on Day 15 up until Day 43
Secondary	Incidence of adverse events	Count and % of events	Day 0 - 43
Secondary	Occurrence of anti-somapacitan antibodies	Count or % of events	Day 0 - 43