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.