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

NCT03186495 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN8640-4297U1111-1187-91412016-003910-29
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximum serum concentration of somapacitan

  After the last dosing on Day 15 up until Day 43

• Time to maximum serum concentration of somapacitan

  After the last dosing on Day 15 up until Day 43

• Incidence of adverse events

  Day 0 - 43

• Occurrence of anti-somapacitan antibodies

  Day 0 - 43

Study Arms (5)

Normal renal function

EXPERIMENTAL

Subjects with normal renal function

Drug: Somapacitan

Mild renal impairment

EXPERIMENTAL

Subjects with mild renal impairment

Drug: Somapacitan

Moderate renal impairment

EXPERIMENTAL

Subjects with moderate renal impairment

Drug: Somapacitan

Severe renal impairment

EXPERIMENTAL

Subjects with severe renal impairment

Drug: Somapacitan

Requiring haemodialysis treatment

EXPERIMENTAL

Subjects requiring haemodialysis treatment

Drug: Somapacitan

Interventions

Somapacitan DRUG

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

Mild renal impairment; Moderate renal impairment; Normal renal function; Requiring haemodialysis treatment; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 33754315 DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitan

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: June 20, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)