drugset / Trial / NCT01028768

Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

NCT01028768

Phase 1 Completed 36 enrolled Nycomed NPS Pharma · collab
Non-randomizedSingle-groupOpen-label

Summary

To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide. Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Timeline

Start
2009-10
Primary completion
2010-01
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 10 mg Subcutaneous