Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and 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: NCT01888393
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE June 20, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date November 19, 2013
Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]
  • Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC [ Time Frame: 16 days ]
  • Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC [ Time Frame: 16 days ]
  • Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry [ Time Frame: 21 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Hepatic Impairment
  • Healthy
Intervention  ICMJE Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
Study Arms  ICMJE
  • Experimental: Group A
    Approximately 12 subjects (male and female) with moderate hepatic impairment
    Intervention: Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
  • Experimental: Group B
    Approximately 12 healthy subjects (male and female)
    Intervention: Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2013)
23
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
24
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888393
Other Study ID Numbers  ICMJE VX13-809-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vertex Pharmaceuticals Incorporated
Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP