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
Overview
- Phase
- Phase 1
- Intervention
- VNZ/TEZ/D-IVA
- Conditions
- Cystic Fibrosis
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Part A: Sequence 1
Participants will receive VNZ/TEZ/D-IVA reference fixed dose combination (FDC) tablet in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.
Intervention: VNZ/TEZ/D-IVA
Part A: Sequence 2
Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 2, and finally VNZ/TEZ/D-IVA reference FDC tablet in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.
Intervention: VNZ/TEZ/D-IVA
Part A: Sequence 3
Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 1, then VNZ/TEZ/D-IVA reference FDC tablet in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.
Intervention: VNZ/TEZ/D-IVA
Part B: Sequence 1
Participants will receive VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.
Intervention: VNZ/TEZ/D-IVA
Part B: Sequence 2
Participants will receive VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.
Intervention: VNZ/TEZ/D-IVA
Outcomes
Primary Outcomes
Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA
Time Frame: Pre-dose up to 288 hours Post-dose
Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA
Time Frame: Pre-dose up to 384 hours Post-dose
Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA
Time Frame: Pre-dose up to 384 hours Post-dose
Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA
Time Frame: Pre-dose up to 288 hours Post-dose
Secondary Outcomes
- 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)
- 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)