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

Phase 1

Completed

• Conditions: In Development for Cystic Fibrosis
• Interventions: Drug: VX-770

• Registration Number: NCT01208285
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-11
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	VX-770	approximately 12 male and female subjects with moderate hepatic impairment
Group B	VX-770	approximately 12 healthy male and female subjects

Primary Outcome Measures

Name	Time	Method
VX-770 pharmacokinetic parameters	4 or 10 Days

Secondary Outcome Measures

Name	Time	Method
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