Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

Inclusion criteria

• All subjects:

• Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment
• Subjects with hepatic impairment:

• Subjects must have either mild, moderate or severe hepatic impairment

Exclusion criteria

• All subjects

• Hepatic impairment due to non-liver disease
• Use of other investigational drugs at time of enrollment
• History of malignancy of any organ system
• Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing
• Hemoglobin levels below 10.0 g/dL at screening or baseline
• Subjects with hepatic impairment:

• Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
• Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist
• Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs

Other protocol-defined inclusion/exclusion criteria may apply.