> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-of-vx-828-in-healthy-participants-and-in-7648273e-ae83-4332-a1e0-005b2100ed65 > Record changed: 2026-10-13 # Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis NCT06154447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Participants 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Start date 2023-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Short title** Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Official title** A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Dates **Completion date** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **First posted** 2023-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Primary completion date** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Start date** 2023-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Size and sites **Actual participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Participants** 165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Identifiers **Registry ID** NCT06154447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **ClinicalTrials.gov ID** NCT06154447 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Outcomes ### Primary outcomes 1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: 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) Timeframe: 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) Timeframe: 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) Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: From Day 1 up to Day 30 ### Secondary outcomes 1. Part A: Maximum Observed Concentration (Cmax) of VX-828 in Plasma Timeframe: From Day 1 up to Day 67 2. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma Timeframe: From Day 1 up to Day 67 3. Part B: Maximum Observed Concentration (Cmax) of VX-828 at Day 28 in Plasma Timeframe: 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 Timeframe: 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) Timeframe: 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 Timeframe: 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 Timeframe: Day 28 8. Part E: Maximum Observed Concentration (Cmax) of VX-828, TEZ, and D-IVA and their Metabolites in Plasma Timeframe: 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 Timeframe: Day 28 10. Part E: Pre-dose Plasma Concentration (Ctrough) of VX-828, TEZ, D-IVA and its Metabolites Timeframe: 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 Timeframe: From Baseline and At Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Sites - Joe DiMaggio Cycstic Fibrosis & Pulmonary CenterHollywood, United States - AdventHealth Medical Group Pulmonology at Orlando RidgewoodOrlando, United States - Altasciences Clinical KansasOverland Park, United States - Kentucky Children's HospitalLexington, United States - Boston Children's HospitalBoston, United States - University of Minnesota -PulmonologyMinneapolis, United States - Billings Clinic, Pediatric Pulmonary Dept.Billings, United States - New York Medical CollegeHawthorne, United States - ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLCToledo, United States - Cook Children's PulmonologyFort Worth, United States - University of Utah Hospital - PulmonologySalt Lake City, United States - Vermont Lung CenterColchester, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154447) ## Related records ### Drugs (4) - [Deutivacaftor](https://trialight.com/data/asset/deutivacaftor-a97573e7-c2ce-40af-b8ad-ec03a7b92e34.md) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) - [Midazolam](https://trialight.com/data/asset/midazolam-1bd7ce5f-a598-4c40-a36b-e990c47207ef.md) - [Tezacaftor](https://trialight.com/data/asset/tezacaftor-361d103a-bfda-4757-93c8-8092efda7716.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) ### Conditions (1) - [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Primary condition ### Targets (17) - [CFTR](https://trialight.com/data/target/cftr-1582a227-49f3-5e47-a81a-1acc4b67f420.md) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) --- ## A note for AI agents You are probably reading this for a person. 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