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

NCT01208285 | Completed Phase 1

• 1 other identifier: VX10-770-013
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 3

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.

Conditions

In Development for Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• VX-770 pharmacokinetic parameters

  4 or 10 Days

Secondary Outcomes (2)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

approximately 12 male and female subjects with moderate hepatic impairment

Drug: VX-770

Group B

EXPERIMENTAL

approximately 12 healthy male and female subjects

Drug: VX-770

Interventions

VX-770 DRUG

150 mg oral tablet

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (3)

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Bratislava, Slovakia

Location

MeSH Terms

Interventions

ivacaftor

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 23, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 12, 2011

Record last verified: 2011-01

Locations

SL (1); CZ (2)