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

Study Overview
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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.

Official Title
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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

Conditions
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In Development for Cystic Fibrosis

Intervention / Treatment
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* Drug: VX-770


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>approximately 12 male and female subjects with moderate hepatic impairment | Drug: VX-770<br>* 150 mg oral tablet<br>|
| Experimental: Group B<br>approximately 12 healthy male and female subjects | Drug: VX-770<br>* 150 mg oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VX-770 pharmacokinetic parameters |  | 4 or 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VX-770 metabolites pharmacokinetic parameters |  | 4 or 10 days | 
| Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs |  | up to 40 days |