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

NCT ID: NCT01208285

Last Updated: 2011-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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In Development for Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

approximately 12 male and female subjects with moderate hepatic impairment

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

150 mg oral tablet

Group B

approximately 12 healthy male and female subjects

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

150 mg oral tablet

Interventions

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VX-770

150 mg oral tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Vertex Pharmaceuticals Incorporated

Locations

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Hradec Králové, , Czechia

Site Status

Prague, , Czechia

Site Status

Bratislava, , Slovakia

Site Status

Countries

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Czechia Slovakia

Other Identifiers

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VX10-770-013

Identifier Type: -

Identifier Source: org_study_id

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