| Outcome Measures: |
Primary: Number of Patients With Reported Adverse Events Receiving Escalating Doses of LHW090 (Part 1), Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented, Adverse events were collected from first dose of study treatment until end of study treatment, (12 days dosing period + 9 days follow up (PART 1) plus 30 days post treatment, up to maximum duration of approximately 20 months|Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (AUC0-t) (PART 1), The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite), Within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs.|Number of Patients Who Developed a Renal Event (PART 2), Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose ), Baseline, within 24 to 48 hours of post-dose weekly for up to 8 weeks | Secondary: Cmax : Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Observed Maximum Plasma Concentration Following Administration of LHW090 (PART 1/PART 2), The observed maximum plasma (or serum or blood) concentration following drug administration for PART 1 and PART 2, PART 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.|AUC0-t: Pharmacokinetics of LHW090/LHV527 (Active Metabolite)in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (PART 2), The area under the plasma concentration-time curve from time zero to 24 hours, PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing|Tmax: Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (PART 1/PART 2), The time to reach the maximum concentration after drug administration, Part 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. Part 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing
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| Locations: |
Novartis Investigative Site, Anaheim, California, 92801, United States|Novartis Investigative Site, Lakewood, Colorado, 80228, United States|Novartis Investigative Site, Miami Lakes, Florida, 33014, United States|Novartis Investigative Site, Orlando, Florida, 32810, United States|Novartis Investigative Site, New Orleans, Louisiana, 70119, United States|Novartis Investigative Site, Minneapolis, Minnesota, 55404, United States|Novartis Investigative Site, Saint Paul, Minnesota, 55114, United States|Novartis Investigative Site, Berlin, 13353, Germany|Novartis Investigative Site, Elsterwerda, 04910, Germany|Novartis Investigative Site, Erlangen, 91054, Germany|Novartis Investigative Site, Hamburg, 22143, Germany|Novartis Investigative Site, Mannheim, 41061, Germany
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