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Clinical Trials/NL-OMON52358
NL-OMON52358CompletedPhase 3

A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - Study Evaluating ELX/TEZ/IVA on glucose tolerance in Subjects With CF

Vertex Pharmaceuticals0 sites8 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
8
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
12 to 64 (—)

Inclusion Criteria

  • •1. Subject (or his or her legally appointed and authorized representative) will
  • •sign and date an informed consent form (ICF), and, when appropriate, an assent
  • •2. Willing and able to comply with scheduled visits, treatment plan, study
  • •restrictions, laboratory tests, contraceptive guidelines, and other study
  • •procedures.
  • •3. Subjects (male and female) 12 years of age or older on the date of informed
  • •4. Subjects heterozygous for F508del and an MF mutation.
  • •a. Genotype should be confirmed at the Screening Visit.
  • •b. If the screening CFTR genotype result is not received before the first dose
  • •of study drug, a previous CFTR genotype laboratory report may be used to
  • •establish eligibility.
  • •c. Subjects who have been enrolled and whose screening genotype does not
  • •confirm study eligibility must be discontinued from the study.
  • •5. Forced expiratory volume in 1 second (FEV1) value >=30% of predicted mean for
  • •age, sex, and height (equations of the Global Lung Function Initiative [GLI])
  • •at the Screening Visit (spirometry measurements must meet American Thoracic
  • •Society/European Respiratory Society criteria for acceptability and
  • •repeatability) and stable CF disease as judged by the investigator.
  • •6. Willing to remain on a stable CF treatment regimen (other than CFTR
  • •modulators) through completion of study participation.
  • •7. Abnormal glucose tolerance as determined by an OGTT, classified as either
  • •IGT (defined as 2-hour post-OGTT blood glucose level >= 140 to <200 mg/dL [>=7.77
  • •to <11.10 mmol/L]) or CFRD (defined as either fasting hyperglycemia [blood
  • •glucose level >=126 mg/dL (>=7.00 mmol/L) after an 8-hour fast] or 2-hour
  • •post-OGTT blood glucose level >=200 mg/dL [>=11.10 mmol/L]).

Exclusion Criteria

  • •1. History of any illness or any clinical condition 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. This includes, but is not
  • •limited to, the following:
  • •Clinically significant liver cirrhosis with or without portal hypertension
  • •Solid organ or hematological transplantation
  • •Alcohol or drug abuse in the past year, including, but not limited to,
  • •cannabis, cocaine, and opiates, as deemed by the investigator
  • •Cancer, except for squamous cell skin cancer, basal cell skin cancer, and
  • •Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5
  • •2. Type 1 or Type 2 diabetes
  • •3. Duration of CFRD >=5 years.
  • •4. Any clinically significant laboratory abnormalities at the Screening Visit
  • •that would interfere with the study assessments or pose an undue risk for the
  • •subject (as deemed by the investigator).
  • •5. Any of the following abnormal laboratory values at screening:
  • •Hemoglobin <10 g/dL
  • •Total bilirubin >=2 × upper limit of normal (ULN)
  • •Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl
  • •transferase (GGT), or alkaline phosphatase (ALP) >=3 × ULN
  • •Abnormal renal function defined as glomerular filtration rate <=50
  • •mL/min/1.73* m2 (calculated by the Modification of Diet in Renal Disease Study
  • •Equation) for subjects >=18 years of age and <=45 mL/min/1.73 m2 (calculated by
  • •the Counahan-Barratt equation) for subjects <18 years of age
  • •6. An acute upper or lower respiratory infection, pulmonary exacerbation, or
  • •changes in therapy (including antibiotics) for pulmonary disease within 28 days
  • •before Day 1 (first dose of study drug).
  • •7. Lung infection with organisms associated with a more rapid decline in
  • •pulmonary status (including, but not limited to, Burkholderia cenocepacia,
  • •Burkholderia dolosa, and Mycobacterium abscessus). For subjects who have had a
  • •history of a positive culture, the investigator will apply the following
  • •criteria to establish whether the subject is free of infection with such
  • •The subject has not had a respiratory tract culture positive for these
  • •organisms within the 12 months before the date of informed consent.
  • •The subject has had at least 2 respiratory tract cultures negative for such
  • •organisms within the 12 months before the date of informed consent, with the
  • •first and last of these separated by at least 3 months, and the most recent one
  • •within the 6 months before the date of informed consent.
  • •8. An acute illness not related to CF (e.g., gastroenteritis) within 14 days
  • •before the first dose of study drug (Day 1).
  • •9. Ongoing or prior participation in an investigational drug study (including
  • •studies investigating ELX with or without coadministration of other study
  • •drugs) within 28 days of the Screening Visit.
  • •A washout period of 5 terminal half lives of the previous investigational
  • •study drug, or 28 days, whichever is longer, must elapse before the Screening
  • •The duration of the elapsed time may be longer if required by local
  • •regulations.
  • •10. Use of restricted medication (including antidiabetic medication other than
  • •insulin, which must be at a dose no greater than 0.3 units/kg/day) within
  • •specified duration before the first dose of study drug.
  • +1 more not shown

Investigators

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