Evaluation of VX-828
Phase 1
255
about 2.4 years
18+
12 sites in FL, KS, KY +8
What this study is about
Researchers are testing a treatment called VX-828. The trial will be given to people with cystic fibrosis and healthy adults. The goal is to see if it's safe and how well it works in these groups.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Deutivacaftor
- 2.Take Itraconazole
- 3.Take Midazolam
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Breast Cancer Resistance Protein Inhibitors, itraconazole (Antifungal; inhibits ergosterol synthesis), midazolam (Benzodiazepine; short-acting)
oral (Oral Capsule), injection
Primary: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), 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, Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of Itraconazole, Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVA, Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of Itraconazole, Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), Part E: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma, Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma, Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-828 at Day 28 in Plasma, Part B: Maximum Observed Concentration (Cmax) of VX-828 at Day 28 in Plasma, Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), 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, Part D: Maximum Observed Concentration (Cmax) of VX-828, TEZ and D-IVA and their Metabolites at Day 28 in Plasma, Part E: Area Under the Concentration Versus Time Curve (AUC) of VX-828, TEZ, and D-IVA and their Metabolites in Plasma
Respiratory