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

Novartis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: RLX030A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433458

CRLX030A2101

2011-001596-39 (EudraCT Number)

Details and patient eligibility

About

This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.

20 to 24 patients and 20 to 24 healthy subjects will be enrolled.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 4 patient groups

RLX030: Group 1 mild hepatic impairment

Experimental group

Description:

Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030

Treatment:

Drug: RLX030A

RLX030: Group 2 moderate hepatic impairment

Experimental group

Description:

Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030

Treatment:

Drug: RLX030A

RLX030: Group 3 severe hepatic impairment

Experimental group

Description:

Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030

Treatment:

Drug: RLX030A

RLX030: Group 4 - healthy volunteers

Active Comparator group

Description:

Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3.

Treatment:

Drug: RLX030A