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Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

Primary Purpose

In Development for Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VX-770
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for In Development for Cystic Fibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Group A (Subjects with Hepatic Impairment):

  • male or female between 18 and 65 years of age
  • subjects must have a Child-Pugh total score of 7 to 9
  • subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study
  • subjects must have a body mass index (BMI) of 18 to 35 kg/m2

Group B (Healthy Subjects):

  • male or female between 18 and 65 years of age
  • subjects will match subjects with hepatic impairment for sex, BMI, cigarette smoking habit, and age
  • subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study

Exclusion Criteria:

Group A (Subjects with Hepatic Impairment):

  • subjects who are not clinically stable or who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
  • subjects who have a history of alcohol abuse within 1 year or illicit drug abuse within 2 years
  • subjects who smoke more than 10 cigarettes per day
  • subjects who have fluctuating or rapidly deteriorating hepatic function
  • subjects who have significant renal dysfunction
  • subjects who have HIV, or active hepatitis B
  • subjects who have previous solid organ or bone marrow transplantation

Group B (Healthy Subjects):

  • subjects who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
  • subjects who have a history of alcohol or illicit drug abuse within 2 years
  • subjects who smoke more than 10 cigarettes per day
  • subjects who have HIV, hepatitis C, or active hepatitis B

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

approximately 12 male and female subjects with moderate hepatic impairment

approximately 12 healthy male and female subjects

Outcomes

Primary Outcome Measures

VX-770 pharmacokinetic parameters

Secondary Outcome Measures

VX-770 metabolites pharmacokinetic parameters
Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs

Full Information

First Posted
September 22, 2010
Last Updated
January 11, 2011
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01208285
Brief Title
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
Official Title
A Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Development for Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
approximately 12 male and female subjects with moderate hepatic impairment
Arm Title
Group B
Arm Type
Experimental
Arm Description
approximately 12 healthy male and female subjects
Intervention Type
Drug
Intervention Name(s)
VX-770
Intervention Description
150 mg oral tablet
Primary Outcome Measure Information:
Title
VX-770 pharmacokinetic parameters
Time Frame
4 or 10 Days
Secondary Outcome Measure Information:
Title
VX-770 metabolites pharmacokinetic parameters
Time Frame
4 or 10 days
Title
Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs
Time Frame
up to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group A (Subjects with Hepatic Impairment): male or female between 18 and 65 years of age subjects must have a Child-Pugh total score of 7 to 9 subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study subjects must have a body mass index (BMI) of 18 to 35 kg/m2 Group B (Healthy Subjects): male or female between 18 and 65 years of age subjects will match subjects with hepatic impairment for sex, BMI, cigarette smoking habit, and age subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study Exclusion Criteria: Group A (Subjects with Hepatic Impairment): subjects who are not clinically stable or who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A subjects who have a history of alcohol abuse within 1 year or illicit drug abuse within 2 years subjects who smoke more than 10 cigarettes per day subjects who have fluctuating or rapidly deteriorating hepatic function subjects who have significant renal dysfunction subjects who have HIV, or active hepatitis B subjects who have previous solid organ or bone marrow transplantation Group B (Healthy Subjects): subjects who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A subjects who have a history of alcohol or illicit drug abuse within 2 years subjects who smoke more than 10 cigarettes per day subjects who have HIV, hepatitis C, or active hepatitis B
Facility Information:
City
Hradec Králové
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Bratislava
Country
Slovakia

12. IPD Sharing Statement

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Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

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