Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06154447

Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Joe DiMaggio Cycstic Fibrosis & Pulmonary Center, Hollywood, Florida, United States

Loading trial locations.

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Parts A-D:

  • Participants between the ages of 18 and 55 years
  • 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
  • Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
  • Cohort C2 only: Willing to provide a single DNA sample

Part E:

  • Participants 18 years or older
  • Confirmed diagnosis of CF as determined by the investigator
  • A total body weight of more than or equal to (>=) 35 kg
  • Participants must be heterozygous for F508del with a second CFTR allele carrying a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
  • Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height

Key Exclusion Criteria:

Parts A-D:

  • History of febrile illness or other acute illness within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption

Part E:

  • An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug
  • History of solid organ or hematological transplantation
  • History of clinically significant cirrhosis with or without portal hypertension
  • Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria will apply.

Treatment and study plan

VX-828

Drug

Suspension for Oral Administration

Placebo

Drug

Suspension for Oral Administration

Itraconazole

Drug

Solution for Oral Administration

midazolam

Drug

Syrup for Oral Administration

Tezacaftor

Drug

Tablets for Oral Administration

Other names: TEZ, VX-661

VX-118

Drug

Tablets for Oral Administration

Deutivacaftor

Drug

Tablets for Oral Administration

Other names: D-IVA, VX-561

Primary outcomes

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 67)

  2. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)

  3. Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)

  4. Part E: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to End of Study (Up to Day 111)

  5. Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of Itraconazole

    Time frame: From Day 1 up to Day 71

  6. Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of Itraconazole

    Time frame: From Day 1 up to Day 71

  7. Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVA

    Time frame: From Day 1 up to Day 30

  8. Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVA

    Time frame: From Day 1 up to Day 30

Secondary outcomes

  1. Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma

    Time frame: From Day 1 up to Day 67

  2. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma

    Time frame: From Day 1 up to Day 67

  3. Part B: Maximum Observed Concentration (Cmax) of VX-828 at Day 28 in Plasma

    Time frame: From Day 1 up to Day 80

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-828 at Day 28 in Plasma

    Time frame: From Day 1 up to Day 80

  5. Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 82)

  6. Part D: Maximum Observed Concentration (Cmax) of VX-828, TEZ and D-IVA and their Metabolites at Day 28 in Plasma

    Time frame: Day 28

  7. Part D: Area Under the Concentration Versus Time Curve (AUC) of VX-828, TEZ and D-IVA and their Metabolites at Day 28 in Plasma

    Time frame: Day 28

  8. Part E: Maximum Observed Concentration (Cmax) of VX-828, TEZ, and D-IVA and their Metabolites in Plasma

    Time frame: Day 1 and Day 28

  9. Part E: Area Under the Concentration Versus Time Curve (AUC) of VX-828, TEZ, and D-IVA and their Metabolites in Plasma

    Time frame: Day 28

  10. Part E: Pre-dose Plasma Concentration (Ctrough) of VX-828, TEZ, D-IVA and its Metabolites

    Time frame: Pre-dose at Day 4, Day 8, Day 15, Day 22, Day 35, Day 49, Day 63, Day 80

  11. Part E: Absolute Change in Sweat Chloride

    Time frame: From Baseline and At Day 28

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.