Health Trials

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

ConditionCystic Fibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days.

Eligibility criteria

Qualifiers

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m²)

A total body weight of more than (>) 50 kg

Male and Female participants of non-childbearing potential

Disqualifiers

History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug

Any condition possibly affecting drug absorption

Trial design

Treatments tested in this trial

  • VX-581
  • Placebo
  • D-IVA
  • TEZ

Treatment groups

136 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov