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

NCT01975337 | Completed Phase 1

• 1 other identifier: CDEB025A2112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

End stage renal disease participants

EXPERIMENTAL

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.

Drug: Alisporivir

Matched healthy participants

ACTIVE COMPARATOR

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.

Drug: Alisporivir

Interventions

Alisporivir DRUG

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

Also known as: DEB025

End stage renal disease participants; Matched healthy participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• the safety or well-being of the participant or study staff;
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
• the analysis of results

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (1)

Novartis Investigative Site

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

alisporivir

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: November 4, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)