The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in combination with deutivacaftor (D-IVA) with or without tezacaftor (TEZ) in healthy subjects.
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in healthy participants. Additionally, VX-272 will be administered in combination with D-IVA with or without TEZ. Note: 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.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Suspension for Oral Administration.
Suspension for Oral Administration.
Tablet for oral administration.
Celerion - Tempe
Tempe, Arizona, United States
RECRUITINGPart 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 34)
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 66)
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 66)
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time frame: From Day 1 up to Day 34
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272
Time frame: From Day 1 up to Day 34
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time frame: From Day 1 up to Day 66
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272
Time frame: From Day 1 up to Day 66
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-272 and its Metabolites
Time frame: From Day 1 up to Day 66
Part C: Maximum Observed Plasma Concentration (Cmax) of TEZ and D-IVA and their Metabolites
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Tablet for oral administration.
Time frame: From Day 1 up to Day 28
Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272 and its Metabolites
Time frame: From Day 1 up to Day 66
Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of TEZ and D-IVA and their Metabolites
Time frame: From Day 1 up to Day 28