Cystic Fibrosis Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, 2-part Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects
The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Key Inclusion Criteria: - Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive - A total body weight greater than (>)50 kg Key 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 - Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug - Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Celerion, Inc. | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
Vertex Pharmaceuticals Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA | Pre-dose up to 288 hours Post-dose | ||
Primary | Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA | Pre-dose up to 384 hours Post-dose | ||
Primary | Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA | Pre-dose up to 288 hours Post-dose | ||
Primary | Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA | Pre-dose up to 384 hours Post-dose | ||
Secondary | Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 42 | ||
Secondary | Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 36 |
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