drugset / Trial / NCT01809184

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

NCT01809184

Phase 1 Completed 84 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.

Timeline

Start
2013-03-04
Primary completion
2013-09-06
Completion
2013-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin icodec Protein / enzyme biologic Oral
Subject insulin glargine Protein / enzyme biologic Subcutaneous