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
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-09-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
approximately 12 male and female subjects with moderate hepatic impairment
VX-770
150 mg oral tablet
Group B
approximately 12 healthy male and female subjects
VX-770
150 mg oral tablet
Interventions
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VX-770
150 mg oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Vertex Pharmaceuticals Incorporated
Locations
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Hradec Králové, , Czechia
Prague, , Czechia
Bratislava, , Slovakia
Countries
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Other Identifiers
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VX10-770-013
Identifier Type: -
Identifier Source: org_study_id
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