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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT01846468

Run by

Novartis Pharmaceuticals

People needed

205

Starts

2013-03-01

Expected to finish

2014-06-28

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• For Stages 1, 2 and 3, subjects fulfilling any of the following additional criteria are not eligible for inclusion in this study:
• An active history of clinically significant ECG abnormalities as determined by the Investigator, or any of the following ECG abnormalities at Screening or Baseline:
• Long QT syndrome
• QTcF > 450 msec (males; at screening)
• QTcF > 460 msec (females; at screening)
• Known history of current clinically significant arrhythmias.
• Use of phosphodiesterase-5 inhibitors, UNLESS subjects agree to discontinue use of the drug for the duration of the study.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
• Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening and at each baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/ml.
• Hemoglobin levels below 11.0 g/dl at screening.
• Subjects in Stage 3 only of the study will be excluded if they have any of the following:
• A history of allergy to topical anesthetic drops
• A history of corneal disease
• A history of eye surgery within three months prior to screening
• A history of corneal surgery (including refractive surgery and corneal transplantation)
• For Stage 4, subjects fulfilling any of the following additional criteria are not eligible for inclusion in this study:
• An active history of clinically significant ECG abnormalities as determined by the Investigator, or any of the following ECG abnormalities at Screening or Baseline:
• Long QT syndrome
• QTcF > 480 msec at screening
• Use of phosphodiesterase-5 inhibitors, UNLESS subjects agree to discontinue use of the drug for the duration of the study.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
• Significant smokers. Significant smokers who are unable to tolerate using no more than 4 cigarettes a day should be excluded
• History of right ventricular dysfunction within the last 12 months

Where it is running

• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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