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

In Development for Cystic Fibrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208285
• Other study ID #: VX10-770-013
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2010
• Last updated: January 11, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• In Development for Cystic Fibrosis

Intervention

Drug:
• VX-770
150 mg oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Czech Republic,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VX-770 pharmacokinetic parameters		4 or 10 Days	No
Secondary	VX-770 metabolites pharmacokinetic parameters		4 or 10 days	No
Secondary	Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs		up to 40 days	Yes