NCT03186495

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-05-17
• Completion: 2018-05-17
• First posted: 2017-06-14
• Last updated: 2020-04-17

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study