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

NCT ID: NCT01975337

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

End stage renal disease participants

End stage renal disease (ESRD) participants received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food at any time during the 2 hours after completion of hemodialysis on Day 1.

Group Type: EXPERIMENTAL

Alisporivir

Intervention Type: DRUG

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

Matched healthy participants

Healthy participants (matched to those with end stage renal disease by sex, age, weight, and smoking status), received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food on Day 1.

Group Type: ACTIVE_COMPARATOR

Alisporivir

Intervention Type: DRUG

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

Interventions

Alisporivir

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

Intervention Type: DRUG

Other Intervention Names

DEB025

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Debiopharm International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Orlando, Florida, United States

Countries

United States

Other Identifiers

CDEB025A2112

Identifier Type: -

Identifier Source: org_study_id