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

NCT ID: NCT03186495

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2018-05-17

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

Subjects with normal renal function

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

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

Mild renal impairment

Subjects with mild renal impairment

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

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

Moderate renal impairment

Subjects with moderate renal impairment

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

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

Severe renal impairment

Subjects with severe renal impairment

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

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

Requiring haemodialysis treatment

Subjects requiring haemodialysis treatment

Group Type: EXPERIMENTAL

Somapacitan

Intervention Type: DRUG

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

Interventions

Somapacitan

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

References

Bentz Damholt B, Dombernowsky SL, Dahl Bendtsen M, Bisgaard C, Hojby Rasmussen M. Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. Clin Pharmacokinet. 2021 Aug;60(8):1015-1027. doi: 10.1007/s40262-021-00990-7. Epub 2021 Mar 23.

Reference Type: DERIVED

PMID: 33754315 (View on PubMed)

Other Identifiers

U1111-1187-9141

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003910-29

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN8640-4297

Identifier Type: -

Identifier Source: org_study_id