Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult 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: NCT03486236
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13 days to healthy male and female subjects

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: VX-440 Drug: TEZ Drug: IVA Drug: Matched Placebos Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects
Actual Study Start Date : July 20, 2016
Actual Primary Completion Date : September 14, 2016
Actual Study Completion Date : September 14, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort C1 Drug: VX-440
VX-440 was administered in TC with TEZ and IVA.

Drug: TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
Other Names:
  • Tezacaftor
  • VX-661

Drug: IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Other Names:
  • Ivacaftor
  • VX-770
Placebo Comparator: Cohort C1: Triple Placebo Drug: Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.
Experimental: Cohort C2 Drug: VX-440
VX-440 was administered in TC with TEZ and IVA.

Drug: TEZ
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
Other Names:
  • Tezacaftor
  • VX-661

Drug: IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Other Names:
  • Ivacaftor
  • VX-770
Placebo Comparator: Cohort C2: Triple Placebo Drug: Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from baseline through safety follow-up visit (up to 29 days) ]

Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) [ Time Frame: from Day 1 through Day 18 ]
  2. Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) [ Time Frame: from Day 1 through Day 18 ]
  3. Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA) [ Time Frame: from Day 1 through Day 18 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects of non-childbearing potential only.
  • Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg.
  • Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ≥80% of their predicted value at screening.

Exclusion Criteria:

  • For female subjects: Pregnant or nursing subjects.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • History of hemolysis.
  • Total bilirubin level >2 × ULN at Screening.

Other protocol defined Inclusion/Exclusion criteria applied.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03486236


Locations
Layout table for location information
United Kingdom
The Medicines Evaluation Unit
Manchester, United Kingdom
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT03486236    
Other Study ID Numbers: VX16-440-002
2016-000762-38 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action