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Completed

NCT Number: NCT01208285

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

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.

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Key information

Conditions

In Development for Cystic Fibrosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-770

Drug

150 mg oral tablet

Primary outcomes

  1. VX-770 pharmacokinetic parameters

    Time frame: 4 or 10 Days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2010
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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