A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

December 16, 2021 updated by: Vertex Pharmaceuticals Incorporated

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Mater Adult Hospital
      • Sydney, Australia
        • Royal Prince Alfred Hospital
      • Sydney, Australia
        • Westmead Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Center
      • Melbourne, Victoria, Australia
        • The Alfred Hospital
      • Parkville, Victoria, Australia
        • The Royal Children's Hospital Melbourne
  • Belgium
      • Edegem, Belgium
        • Antwerp University Hospital
      • Gent, Belgium
        • Universitair Ziekenhuis Gent
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Centre
      • Den Haag, Netherlands
        • HagaZiekenhuis van Den Haag
      • Nijmegen, Netherlands
        • Radboud UMC
      • Rotterdam, Netherlands
        • Erasmus Medical Center
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Banner University of Arizona Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Madera, California, United States, 93636
        • Valley Children's Healthcare
      • Oakland, California, United States, 96411
        • (Kaiser Permanente) Oakland Medical Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital Cardiac and Lung Transplant Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30324
        • Children's Specialty Services at North Druid Hills
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit Inc., Evansville Clinic [Parts A, B, C only]
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • UC Health Office of Clinical Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center/Rainbow Babies and Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Texas
      • Austin, Texas, United States, 78723
        • Austin Children's Chest Associates
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Morgantown, Virginia, United States, 26506
        • West Virginia University Hospitals
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Parts A, B, and C:

  • Female subjects must be of non-childbearing potential.
  • Between the ages of 18 and 55 years, inclusive.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D, E, and F:

  • Body weight ≥35 kg.

  • Subjects must have an eligible CFTR genotype:

    • Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)
    • Part E: Homozygous for F508del (F/F)
  • FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:

  • Any condition possibly affecting drug absorption.
  • History of febrile illness within 14 days before the first study drug dose.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D, E, and F:

  • History of clinically significant cirrhosis with or without portal hypertension.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.
  • History of solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Part A: Pooled Placebo (Except Cohort A7)
Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
Drug: Matched Placebo
Matched placebo.
Experimental: Part A: VX-445 (Except Cohort A7)
Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Experimental: Part A: VX-445 (Cohort A7)
Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Placebo Comparator: Part B: Pooled Placebo (Cohort B1 to B4)
Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
Drug: Matched Placebo
Matched placebo.
Experimental: Part B: VX-445 (Cohort B1 to B4)
Participants without CF who received VX-445 tablet qd for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Placebo Comparator: Part C: Pooled Placebo (Cohort C1 to C3)
Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) qd in the morning and placebo matched to IVA in the evening for 14 days.
Drug: Matched Placebo
Matched placebo.
Experimental: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: IVA
IVA tablet for oral administration
Other Names:
  • VX-770
  • ivacaftor
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Placebo Comparator: Part D: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA qd in the evening for 4 weeks in the TC treatment period.
Drug: Matched Placebo
Matched placebo.
Experimental: Part D: VX-445/TEZ/IVA TC - Low Dose
Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: IVA
IVA tablet for oral administration
Other Names:
  • VX-770
  • ivacaftor
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Experimental: Part D: VX-445/TEZ/IVA TC - Medium Dose
Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: IVA
IVA tablet for oral administration
Other Names:
  • VX-770
  • ivacaftor
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Experimental: Part D: VX-445/TEZ/IVA TC - High Dose
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: IVA
IVA tablet for oral administration
Other Names:
  • VX-770
  • ivacaftor
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Active Comparator: Part E: TEZ/IVA
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Experimental: Part E: VX-445/TEZ/IVA TC
Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: IVA
IVA tablet for oral administration
Other Names:
  • VX-770
  • ivacaftor
Drug: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Other Names:
  • VX-661/VX-770
  • tezacaftor/ivacaftor
Placebo Comparator: Part F: Placebo
Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
Drug: Matched Placebo
Matched placebo.
Experimental: Part F: VX-445/TEZ/VX-561 TC
Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
Drug: VX-445
VX-445 tablet for oral administration.
Other Names:
  • ELX
  • elexacaftor
Drug: VX-445
VX-445 IV injection
Other Names:
  • ELX
  • elexacaftor
Drug: TEZ
Tablet for oral administration.
Other Names:
  • VX-661
  • tezacaftor
Drug: VX-561
Tablet for oral administration.
Other Names:
  • CTP-656

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose of study drug in treatment period up to safety follow-up (up to 28 days)
From first dose of study drug in treatment period up to safety follow-up (up to 28 days)
Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29
Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29
Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Maximum Observed Concentration (Cmax) of VX-445
Time Frame: Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
Time Frame: Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
Part B: Maximum Observed Concentration (Cmax) of VX-445
Time Frame: Pre-dose to 96 hours post-dose on Day 1 and Day 10
Pre-dose to 96 hours post-dose on Day 1 and Day 10
Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
Time Frame: Pre-dose to 96 hours post-dose on Day 1 and Day 10
Pre-dose to 96 hours post-dose on Day 1 and Day 10
Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445
Time Frame: Pre-dose on Day 10
Pre-dose on Day 10
Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
Time Frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
Time Frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
Time Frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
Time Frame: Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
Time Frame: Pre-dose on Day 7 and Day 14
Pre-dose on Day 7 and Day 14
Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
Time Frame: Pre-dose on Day 7 and Day 14
Pre-dose on Day 7 and Day 14
Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
Time Frame: Pre-dose on Day 15 and Day 29
Pre-dose on Day 15 and Day 29
Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
Time Frame: Pre-dose on Day 15 and Day 29
Pre-dose on Day 15 and Day 29
Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
Time Frame: Pre-dose on Day 15 and Day 29
Pre-dose on Day 15 and Day 29
Part D: Absolute Change in Sweat Chloride Concentration
Time Frame: From Baseline through Day 29
Sweat samples were collected using an approved collection device.
From Baseline through Day 29
Part E: Absolute Change in Sweat Chloride Concentration
Time Frame: From Baseline through Day 29
Sweat samples were collected using an approved collection device.
From Baseline through Day 29
Part F: Absolute Change in Sweat Chloride Concentration
Time Frame: From Baseline through Day 29
Sweat samples were collected using an approved collection device.
From Baseline through Day 29
Part D: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29
Part E: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29
Part F: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Time Frame: From Baseline through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
From Baseline through Day 29
Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
Time Frame: From Baseline through Day 29
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
From Baseline through Day 29
Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
Time Frame: From Baseline through Day 29
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
From Baseline through Day 29
Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
Time Frame: From Baseline through Day 29
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
From Baseline through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VX16-445-001
  • 2017-000797-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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