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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: In Development for Cystic Fibrosis

Treatments: Drug: VX-770

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208285

VX10-770-013

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group A

Experimental group

Description:

approximately 12 male and female subjects with moderate hepatic impairment

Treatment:

Drug: VX-770

Group B

Experimental group

Description:

approximately 12 healthy male and female subjects

Treatment:

Drug: VX-770