NCT01846468

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

A Partially-blinded, Randomized, Placebo-controlled, Adaptive Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Renal Insufficiency

Interventions

Type	Name	Description
DRUG	LHW090	1 mg, 12.5 mg, 100 mg capsules
DRUG	Placebo	Matching placebo capsules

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-28
• Completion: 2014-06-28
• First posted: 2013-05-03
• Last updated: 2020-12-17

Locations

2 sites across 1 country: United States