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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: RLX030A

• Registration Number: NCT01433458
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-14
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RLX030: Group 2 moderate hepatic impairment	RLX030A	Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030
RLX030: Group 4 - healthy volunteers	RLX030A	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.
RLX030: Group 1 mild hepatic impairment	RLX030A	Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030
RLX030: Group 3 severe hepatic impairment	RLX030A	Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030

Primary Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve from time zero to infinity (AUCinf)	Up to Day 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)	Up to Day 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Serum concentration at 24 hour (C24h) after administration	Upto Day 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events, serious adverse events and death	Day 15	Monitoring of adverse events, serious adverse events and death from screening to end of study
Terminal elimination half life (T ½) of RLX030	screening, days 1, 2, 3, 4 and 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Systemic clearance of RLX030 from serum (CL)	screening, days 1, 2, 3, 4 and 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Volume of distribution at steady state (Vss)	screening, days 1, 2, 3, 4 and 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Determination of the presence and quantification of anti-RLX030 antibodies	Day 1 (prior to administration) and Day 15 end of study	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
Mean residence time [MRT] of RLX030	screening, days 1, 2, 3, 4 and 15	Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Moscow, Russian Federation