Back to resultsA Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
VX-440
TEZ
IVA
Matched Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility 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.
Sites / Locations
- The Medicines Evaluation Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cohort C1
Cohort C1: Triple Placebo
Cohort C2
Cohort C2: Triple Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT03486236
First Posted
March 27, 2018
Last Updated
March 27, 2018
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03486236
Brief Title
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
September 14, 2016 (Actual)
Study Completion Date
September 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort C1
Arm Type
Experimental
Arm Title
Cohort C1: Triple Placebo
Arm Type
Placebo Comparator
Arm Title
Cohort C2
Arm Type
Experimental
Arm Title
Cohort C2: Triple Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VX-440
Intervention Description
VX-440 was administered in TC with TEZ and IVA.
Intervention Type
Drug
Intervention Name(s)
TEZ
Other Intervention Name(s)
Tezacaftor, VX-661
Intervention Description
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
Intervention Type
Drug
Intervention Name(s)
IVA
Other Intervention Name(s)
Ivacaftor, VX-770
Intervention Description
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Intervention Type
Drug
Intervention Name(s)
Matched Placebos
Intervention Description
Placebos matched to VX-440, TEZ, and IVA.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The Medicines Evaluation Unit
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
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