This study is currently not recruiting participants.

A Phase 3 Open-label Study to Evaluate the Pharmacokinetics Safety and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis Homozygous or Heterozygous for the F508del-CFTR Mutation

Study on Investigational Medication Effects

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The purpose of this study is to evaluate the PK of VX-661 and ivacaftor after administration of multiple doses of VX-661 in combination with ivacaftor.

Detailed description of study

The purpose of this study is to evaluate the PK of VX-661 and ivacaftor after administration of multiple doses of VX-661 in combination with ivacaftor.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cystic fibrosis
  • Age: 100 years or below
  • Gender: All

This study investigates the effects of an investigational medication on individuals with cystic fibrosis. Cystic fibrosis is a genetic disorder that affects the lungs and digestive system, causing mucus to become thick and sticky. This can lead to blockages and infections.

Participants will receive multiple doses of the investigational medication. The study will monitor how the body processes the medication over time, which is known as pharmacokinetics. This will help understand how the medication is absorbed, distributed, and eliminated from the body.

  • Who can participate: Information about who can participate is currently unavailable. Typically, eligibility includes age, health condition, and other factors specific to the study's requirements.
  • Study details: Participants will take the investigational medication in combination with another substance to observe its effects. The study will involve monitoring the body's response to these medications. If a placebo is used, it is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1609426311

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