NCT01600976

Brief Summary

The purpose of this study is to determine whether the pharmacokinetic (what the body does to the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment, compared to the pharmacokinetic parameters in patients with normal liver function, and measure the relative unbound plasma concentrations of telaprevir.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
2 countries

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

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

May 15, 2012

Last Update Submit

November 8, 2013

Conditions

Hepatic Impairment

Keywords

Hepatic impairmentHepatitis CTelaprevirVX-950PharmacokineticsSafetyUnbound plasma concentrationsChild-Pugh score

Outcome Measures

Primary Outcomes (3)

  • Comparing the maximum plasma analyte concentration (Cmax) of telaprevir in patients of Group 2 and Group 1

    The pharmacokinetic parameter Cmax of telaprevir following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB \[Child-Pugh score 7 to 9\]) ie, Group 1, as compared to matched healthy patients ie, Group 2

    Day 1 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), Day 2 to Day 5 (predose), Day 6 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), and Day 7 (24 hour)

  • Comparing the area under the plasma concentration-time curve (AUC8h) of telaprevir in patients of Group 2 and Group 1

    The pharmacokinetic parameter AUC8h will be measured from time of administration up to 8 hours post dose of telaprevir following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB) ie, Group 1, as compared to matched healthy patients ie, Group 2

    Day 1 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), Day 2 to Day 5 (predose), Day 6 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), and Day 7 (24 hour)

  • Comparing the actual sampling time to reach the maximum plasma analyte concentration (tmax) of telaprevir in patients of Group 2 and Group 1

    The pharmacokinetic parameter tmax will be measured following administration of single and multiple oral doses of telaprevir in patients with moderate hepatic impairment (CPB) ie, Group 1, as compared to matched healthy patients ie, Group 2

    Day 1 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), Day 2 to Day 5 (predose), Day 6 (-1 hour, predose, 0, 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 12, 15, 18 hours postdose), and Day 7 (24 hour)

Secondary Outcomes (3)

  • Number of adverse events in Group 1 patients as a measure of safety

    up to Day 6

  • Comparing unbound fractions of telaprevir in patients of Group 1 and Group 2

    up to Day 6

  • Comparing any relationship between the measures of hepatic function and selected pharmacokinetic parameters of telaprevir in patients of Group 1 and Group 2

    up to Day 6

Study Arms (3)

Group 1

EXPERIMENTAL

10 patients with moderate hepatic impairment (CPB \[Child-Pugh score 7 to 9\])

Drug: telaprevir

Group 2

EXPERIMENTAL

10 healthy control patients with normal hepatic function. Each healthy control patient is matched to a patient in Group 1 with respect to sex, age (± 5 years) and body mass index (BMI) (± 15%)

Drug: telaprevir

Group 3

EXPERIMENTAL

up to 4 patients with severe hepatic impairment (CPC \[limited to Child Pugh score 10 to 12\])

Drug: telaprevir

Interventions

telaprevirDRUG

Type=exact number, unit=mg, number=375, form=tablet, route=oral. Multiple doses of 2 oral tablets of telaprevir will be administered every 8 hours on Days 1 to 5 and a single dose of 2 oral tablets of telaprevir will be administered in the morning on Day 6.

Also known as: VX-950
Group 1Group 2Group 3

Eligibility Criteria

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

You may qualify if:

  • For Group 1:
  • Moderate liver function impairment (Child Pugh score of 7 to 9)
  • History of hepatic disease, such as hepatitis B, previous hepatitis C, alcoholic liver disease, autoimmune hepatitis, non-alcoholic fatty liver disease, hereditary/metabolic, cryptogenic, other
  • Consistent with the disease process of hepatic impairment and associated symptoms
  • For Group 2:
  • \- Matched to a patient with moderate hepatic impairment with regards to sex, age (± 5 years), and BMI (± 15%) and healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality
  • For Group 3:
  • Severe liver function impairment (limited to Child Pugh score of 10 to 12)
  • Hepatic impairment due to different etiologies such as hepatitis B, previous hepatitis C, alcoholic liver disease, autoimmune hepatitis, non-alcoholic fatty liver disease, hereditary/metabolic, cryptogenic, other
  • Consistent with the disease process of hepatic impairment and associated symptoms

You may not qualify if:

  • For Group 1 and 3:
  • Has acute infectious hepatitis
  • Has grade 3 or 4 encephalopathy
  • Has grade 3 or 4 creatinine elevation
  • Is an active candidate for liver transplantation
  • Has had variceal bleeding or spontaneous bacterial peritonitis
  • For Group 1 only:
  • \- Has a porta-caval shunt or transjugular intrahepatic porto-systemic shunts
  • For Group 2:
  • Has acute hepatitis A or hepatitis B or hepatitis C infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Kiel, Germany

Location

Related Publications (1)

  • Ouwerkerk-Mahadevan S, Halabi A, Cieslarova B, Aerts I, Witek J, Van Solingen-Ristea R, Luo D. Pharmacokinetics of bound and unbound telaprevir in cirrhotic patients with moderate and severe hepatic impairment. J Clin Pharmacol. 2015 Oct;55(10):1147-56. doi: 10.1002/jcph.545. Epub 2015 Jul 7.

    PMID: 25975934DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Janssen Infectious Diseases BVBA Clinical Trial

    Janssen Infectious Diseases BVBA

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

CZ(1)DE(1)