CompletedPhase 1

Effect of Hepatic Impairment on LDE225..

United States, Belgium, Bulgaria33 participantsStarted 2013-03

Plain-language summary

This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓Subjects with confirmed cirrhosis

What they're measuring

LDE225A pharmacokinetic parameter Tmax

Timeframe: 8 weeks

LDE225A pharmacokinetic parameter Cmax

Timeframe: 8 weeks

LDE225A pharmacokinetic parameter AUClast

Timeframe: 8 weeks

LDE225A pharmacokinetic parameter AUCinf

Timeframe: 8 weeks

LDE225A pharmacokinetic parameter T1/2

Timeframe: 8 weeks

Trial details

NCT IDNCT01764776

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Normal Hepatic Function trials