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

Hepatic Impairment Clinical Trial

Official title:

A Single-dose, Open-label Parallel Study to Assess the Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433458
• Other study ID #: CRLX030A2101
• Secondary ID: 2011-001596-39
• Status: Completed
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• RLX030A
RLX030 is administered as a continuous 24 hour infusion

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Grunstadt
Russian Federation	Novartis Investigative Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration-time curve from time zero to infinity (AUCinf)	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	Up to Day 15
Primary	Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	Up to Day 15
Primary	Serum concentration at 24 hour (C24h) after administration	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	Upto Day 15
Secondary	Number of patients with adverse events, serious adverse events and death	Monitoring of adverse events, serious adverse events and death from screening to end of study	Day 15
Secondary	Determination of the presence and quantification of anti-RLX030 antibodies	Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies. Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach	Day 1 (prior to administration) and Day 15 end of study
Secondary	Mean residence time [MRT] of RLX030	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	screening, days 1, 2, 3, 4 and 15
Secondary	Terminal elimination half life (T ½) of RLX030	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	screening, days 1, 2, 3, 4 and 15
Secondary	Systemic clearance of RLX030 from serum (CL)	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	screening, days 1, 2, 3, 4 and 15
Secondary	Volume of distribution at steady state (Vss)	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030	screening, days 1, 2, 3, 4 and 15

External Links

•   Results for CRLX030A2101 can be found on the Novartis Clinical Trial Results Website