NCT01860326

Brief Summary

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

February 21, 2012

Last Update Submit

April 27, 2016

Conditions

Hepatic Insufficiency

Keywords

hepatic impairmentmild and moderate hepatic impairmentAlisporivir

Outcome Measures

Primary Outcomes (2)

  • Maximum Concentration (Cmax) of alisporivir

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  • Area under the time-concentration curve (AUC) for alisporivir

    Categories: AUC up to the last measurable concentration (AUClast) and AUC from time 0 to the last time point measured (AUC0-t)

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

Secondary Outcomes (4)

  • Time to maximum concentration (Tmax) of alisporivir

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  • Half-Life (T1/2) of alisporivir

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  • Apparent total body clearance from plasma (CL/F) of alisporivir

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

  • Apparent volume of distribution (Vz/F) of alisporivir

    0.5 h (± 5 min), 1 h (± 10 min), 2 h (± 10 min), 4 h (± 30 min), 6 h (± 30 min), 8 h (± 30 min), 12 h (± 30 min), 24 h (± 60 min), 48 h (± 60 min), 72 h (± 60 min), 96 h (± 60 min), 120 h (± 60 min), 144 h (± 60 min), and 168 h (± 60 min) post-dose

Study Arms (1)

Alisporivir

EXPERIMENTAL

Single 200 mg oral dose

Drug: Alisporivir

Interventions

AlisporivirDRUG

Capsules supplied as open labeled bulk medication in 10-unit blister packages

Also known as: DEB025
Alisporivir

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 to 70 years of age, in good health
  • Stable Child-Turcotte-Pugh score of at least 5
  • Body weight of at least 50 kg and a BMI of 18.0 to 36.0 kg/m2

You may not qualify if:

  • Use of other investigational drugs
  • Women of child-bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Hepatic InsufficiencyLymphoma, Follicular

Interventions

alisporivir

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Study Director

    Novartis Institutes for BioMedical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

May 22, 2013

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(2)