Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
NCT ID: NCT01433458
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2011-07-31
2011-12-31
Brief Summary
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20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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RLX030: Group 1 mild hepatic impairment
Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030
RLX030A
RLX030 is administered as a continuous 24 hour infusion
RLX030: Group 2 moderate hepatic impairment
Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030
RLX030A
RLX030 is administered as a continuous 24 hour infusion
RLX030: Group 3 severe hepatic impairment
Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030
RLX030A
RLX030 is administered as a continuous 24 hour infusion
RLX030: Group 4 - healthy volunteers
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.
RLX030A
RLX030 is administered as a continuous 24 hour infusion
Interventions
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RLX030A
RLX030 is administered as a continuous 24 hour infusion
Eligibility Criteria
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Inclusion Criteria
• 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Grünstadt, , Germany
Novartis Investigative Site
Moscow, , Russia
Countries
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References
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Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.
Related Links
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Results for CRLX030A2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2011-001596-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2101
Identifier Type: -
Identifier Source: org_study_id