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Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects

NCT01975337 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-08-17

No results posted yet for this study

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.

Conditions

  • Kidney Failure, Chronic

Interventions

DRUG

Alisporivir

Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975337 on ClinicalTrials.gov