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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: Somapacitan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03186495

U1111-1187-9141 (Other Identifier)

2016-003910-29 (Registry Identifier)

NN8640-4297

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 5 patient groups

Normal renal function

Experimental group

Description:

Subjects with normal renal function

Treatment:

Drug: Somapacitan

Mild renal impairment

Experimental group

Description:

Subjects with mild renal impairment

Treatment:

Drug: Somapacitan

Moderate renal impairment

Experimental group

Description:

Subjects with moderate renal impairment

Treatment:

Drug: Somapacitan

Severe renal impairment

Experimental group

Description:

Subjects with severe renal impairment

Treatment:

Drug: Somapacitan

Requiring haemodialysis treatment

Experimental group

Description:

Subjects requiring haemodialysis treatment

Treatment:

Drug: Somapacitan