drugset / Trial / NCT01846468

An Ascending Dose Study to Assess Safety, Tolerability, PK/PD of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction

NCT01846468 ↗

Phase 1 Completed 205 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of the study is to provide pertinent information to enable decisions regarding the developability of LHW090 for use in patients with chronic renal insufficiency, including a comparison of the potential risk-benefit ratio of several doses of the study drug to enable optimal doses to be tested in later studies.

Timeline

Start
2013-03-01
Primary completion
2014-06-28
Completion
2014-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject LHW090 Unknown 1 mg —
Subject LHW090 Unknown 12.5 mg —
Subject LHW090 Unknown 100 mg —