Kidney Failure, Chronic
Conditions
Brief summary
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.
Interventions
DRUGAlisporivir
Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
Sponsors
Debiopharm International SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provides written informed consent before any assessment is performed * Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments * ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits * Weighs at least 50 kg * Is able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion criteria
* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff; 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3. the analysis of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
| Area under the plasma concentration-time curve for alisporivir from time zero to time 'infinity' [mass x time / volume] (AUCinf) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
| Area under the plasma concentration-time curve for alisporivir from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| The terminal elimination half-life [time] (T1/2) for alisporivir | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
| The apparent volume of distribution during the terminal elimination phase following extravascular administration of alisporivir [volume] (Vz/F) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
| Time to reach peak or maximum concentration of alisporivir following drug administration [time] (Tmax) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
| Apparent systemic (or total body) clearance from plasma following extravascular administration of alisporivir [volume / time] (CL/F) | Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose |
Countries
United States
Outcome results
None listed