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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VX-121/TEZ/D-IVA
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 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.

Sites / Locations

  • ICON Salt Lake City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA
Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA

Secondary Outcome Measures

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
September 7, 2022
Last Updated
December 8, 2022
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05535959
Brief Title
A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor
Official Title
A Phase 1, Randomized, Open-label, Crossover Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121, Tezacaftor, and Deutivacaftor in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
VX-121/TEZ/D-IVA
Other Intervention Name(s)
VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, VX-121/tezacaftor/deutivacaftor
Intervention Description
FDC tablet for oral administration.
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA
Time Frame
Pre-dose up to 288 hours Post-dose
Title
Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA
Time Frame
Pre-dose up to 288 hours Post-dose
Secondary Outcome Measure Information:
Title
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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.
Facility Information:
Facility Name
ICON Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

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

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