A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects

March 27, 2018 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

  • United Kingdom
      • Manchester, United Kingdom
        • The Medicines Evaluation Unit

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

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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:
  • VX-661
  • Tezacaftor
Drug: IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Other Names:
  • VX-770
  • Ivacaftor
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:
  • VX-661
  • Tezacaftor
Drug: IVA
IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
Other Names:
  • VX-770
  • Ivacaftor
PLACEBO_COMPARATOR: Cohort C2: Triple Placebo
Drug: Matched Placebos
Placebos matched to VX-440, TEZ, and IVA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
from baseline through safety follow-up visit (up to 29 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: from Day 1 through Day 18
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)
Time Frame: from Day 1 through Day 18
from Day 1 through Day 18

Collaborators and Investigators

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

Sponsor

Vertex Pharmaceuticals Incorporated

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)

July 20, 2016

Primary Completion (ACTUAL)

September 14, 2016

Study Completion (ACTUAL)

September 14, 2016

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

April 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX16-440-002
  • 2016-000762-38 (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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