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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01208285
• Date of registration: 22/09/2010
• Prospective Registration: No
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
• Scientific title: 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
• Date of first enrolment: September 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01208285
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Czech Republic, Slovakia

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

In Development for Cystic Fibrosis

Intervention(s)

Drug: VX-770

Primary Outcome(s)

VX-770 pharmacokinetic parameters [Time Frame: 4 or 10 Days]

Secondary Outcome(s)

Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs [Time Frame: up to 40 days]

VX-770 metabolites pharmacokinetic parameters [Time Frame: 4 or 10 days]

Secondary ID(s)

VX10-770-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors