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

Purpose

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.

Condition

  • Cystic Fibrosis

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2) - A total body weight of more than (>) 50 kg - Male and Female participants of non-childbearing potential

Exclusion Criteria

  • 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 Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Single Ascending Dose 		Participants will be randomized to receive a single dose of VX-581.
  • Drug: VX-581
    Suspension for Oral Administration.
Placebo Comparator
Placebo: Part A 		Participants will be randomized to receive a single dose of placebo matched to VX-581.
  • Drug: Placebo
    Suspension for Oral Administration.
Experimental
Part B: Multiple Ascending Dose 		Participants will be randomized to receive multiple doses of VX-581.
  • Drug: VX-581
    Suspension for Oral Administration.
Placebo Comparator
Placebo: Part B 		Participants will be randomized to receive multiple doses of placebo matched to VX-581.
  • Drug: Placebo
    Suspension for Oral Administration.
Experimental
Part C: VX-581 with TEZ/D-IVA or D-IVA 		Participants will be randomized to receive multiple doses VX-581 in combination with TEZ/D-IVA or D-IVA.
  • Drug: VX-581
    Suspension for Oral Administration.
  • Drug: D-IVA
    Tablet for Oral Administration.
    Other names:
    • deutivacaftor
  • Drug: TEZ
    Tablet for Oral Administration.
    Other names:
    • tezacaftor
Placebo Comparator
Placebo: Part C 		Participants will be randomized to receive placebo matched to VX-581 in combination with TEZ/D-IVA or D-IVA.
  • Drug: Placebo
    Suspension for Oral Administration.
  • Drug: D-IVA
    Tablet for Oral Administration.
    Other names:
    • deutivacaftor
  • Drug: TEZ
    Tablet for Oral Administration.
    Other names:
    • tezacaftor

Recruiting Locations

Altasciences - Kansas City
Overland Park, Kansas 66212

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Detailed Description

The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Additionally, VX-581 will also be administered in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days. Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).