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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01208285
First received: September 22, 2010
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
In Development for Cystic Fibrosis
Drug: VX-770
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • VX-770 pharmacokinetic parameters [ Time Frame: 4 or 10 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VX-770 metabolites pharmacokinetic parameters [ Time Frame: 4 or 10 days ] [ Designated as safety issue: No ]
  • Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs [ Time Frame: up to 40 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208285

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

No publications provided

Responsible Party: Medical Monitor, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01208285     History of Changes
Other Study ID Numbers: VX10-770-013
Study First Received: September 22, 2010
Last Updated: January 11, 2011
Health Authority: Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Liver Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014