Hepatic Impairment
Conditions
Keywords
Hepatic impairment, healthy volunteers, RLX030, pharmacokinetics
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.
Interventions
DRUGRLX030A
RLX030 is administered as a continuous 24 hour infusion
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Germany, Russia
Outcome results
None listed