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Clinical Trial Details

Trial ID: L0518
Source ID: NCT01975337
Associated Drug: Alisporivir
Title: Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Alisporivir
Outcome Measures: Primary: 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: 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|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|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|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
Sponsor/Collaborators: Sponsor: Debiopharm International SA
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
Start Date: 2013-08
Completion Date: 2014-02
Results First Posted:
Last Update Posted: 2016-08-17
Locations: Novartis Investigative Site, Orlando, Florida, 32809, United States
URL: https://clinicaltrials.gov/show/NCT01975337