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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01208285
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
In Development for Cystic Fibrosis Drug: VX-770 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group A
approximately 12 male and female subjects with moderate hepatic impairment
Drug: VX-770
150 mg oral tablet
Experimental: Group B
approximately 12 healthy male and female subjects
Drug: VX-770
150 mg oral tablet


Outcome Measures

Primary Outcome Measures :
  1. VX-770 pharmacokinetic parameters [ Time Frame: 4 or 10 Days ]

Secondary Outcome Measures :
  1. VX-770 metabolites pharmacokinetic parameters [ Time Frame: 4 or 10 days ]
  2. Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs [ Time Frame: up to 40 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208285


Locations
Czech Republic
Hradec Králové, Czech Republic
Praha, Czech Republic
Slovakia
Bratislava, Slovakia
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information

Responsible Party: Medical Monitor, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01208285     History of Changes
Other Study ID Numbers: VX10-770-013
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action