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Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01888393
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Healthy Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
Study Start Date : June 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Approximately 12 subjects (male and female) with moderate hepatic impairment
 Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
Experimental: Group B
Approximately 12 healthy subjects (male and female)
 Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h


Outcome Measures
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Primary Outcome Measures :
  1. Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]
  2. Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]

Secondary Outcome Measures :
  1. Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC [ Time Frame: 16 days ]
  2. Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC [ Time Frame: 16 days ]
  3. Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry [ Time Frame: 21 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

  • Male and female 18 to 65 years of age (inclusive)
  • Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
  • Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.

Group B: Healthy subjects

  • Male and female 18 to 65 years of age (inclusive)
  • Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
  • Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures

Exclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

  • History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
  • Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
  • Severe hepatic encephalopathy
  • Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
  • Hepatocellular carcinoma, HIV, hepatitis B/C
  • Significant renal dysfunction
  • Solid organ or bone marrow transplantation
  • History of regular alcohol consumption, drug abuse or regular smoking

Group B: Healthy subjects

  • History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • History of regular alcohol consumption, drug abuse or regular smoking
Contacts and Locations
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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): NCT01888393


Locations
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Czech Republic
Praha, Czech Republic
Slovakia
Bratislava, Slovakia
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01888393    
Other Study ID Numbers: VX13-809-010
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Vertex Pharmaceuticals Incorporated:
pharmacokinetics, hepatic impairment
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Ivacaftor
 Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action