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

Phase 1 Completed 44 enrolled Novo Nordisk A/S

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2017-06-20
Primary completion: 2018-05-17
Completion: 2018-05-17

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	somapacitan	Protein / enzyme biologic	0.08 mg/kg	Subcutaneous

Indications

No indication recorded.