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A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor

Phase 1
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: VX-121/TEZ/D-IVA
Registration Number
NCT05535959
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Brief Summary

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/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.).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

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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 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
  • History of cardiovascular disease or central nervous system disease

Other protocol defined Inclusion/Exclusion criteria may apply.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sequence 1VX-121/TEZ/D-IVAParticipants will receive a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.
Sequence 2VX-121/TEZ/D-IVAParticipants will receive a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.
Primary Outcome Measures
NameTimeMethod
Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVAPre-dose up to 288 hours Post-dose
Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVAPre-dose up to 288 hours Post-dose
Secondary Outcome Measures
NameTimeMethod
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Day 1 up to Day 28

Trial Locations

Locations (1)

ICON Salt Lake City

🇺🇸

Salt Lake City, Utah, United States

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