In Development for Cystic Fibrosis
Conditions
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.
Interventions
DRUGVX-770
150 mg oral tablet
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VX-770 pharmacokinetic parameters | 4 or 10 Days |
Secondary
| Measure | 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 |
Countries
Czechia, Slovakia
Outcome results
None listed