A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
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
2 other identifiers
interventional
16
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2016
CompletedFirst Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedApril 3, 2018
March 1, 2018
2 months
March 27, 2018
March 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
from baseline through safety follow-up visit (up to 29 days)
Secondary Outcomes (3)
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)
from Day 1 through Day 18
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)
from Day 1 through Day 18
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)
from Day 1 through Day 18
Study Arms (4)
Cohort C1
EXPERIMENTALCohort C1: Triple Placebo
PLACEBO COMPARATORCohort C2
EXPERIMENTALCohort C2: Triple Placebo
PLACEBO COMPARATORInterventions
TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Placebos matched to VX-440, TEZ, and IVA.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- For female subjects: Pregnant or nursing subjects.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History of hemolysis.
- Total bilirubin level \>2 × ULN at Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Medicines Evaluation Unit
Manchester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 3, 2018
Study Start
July 20, 2016
Primary Completion
September 14, 2016
Study Completion
September 14, 2016
Last Updated
April 3, 2018
Record last verified: 2018-03