drugset / Trial / NCT01504165

Pharmacokinetics in Subjects With Renal Impairment

NCT01504165

Phase 1 Completed 32 enrolled Merck KGaA, Darmstadt, Germany
Non-randomizedParallel-groupOpen-label

Summary

This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different grades of renal impairment as compared to subjects with normal renal function.

Timeline

Start
2012-01
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject cilengitide Peptide 1000 mg Intravenous
Subject cilengitide Peptide 2000 mg Intravenous