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Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05437120
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: VX-121/TEZ/D-IVA Phase 1

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.).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of VX-121/Tezacaftor/Deutivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
Actual Study Start Date : July 22, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .
Drug: VX-121/TEZ/D-IVA
Fixed-dose combination tablets for oral administration.
Other Names:
  • VX-121/VX-661/VX-561
  • VX-121/VX-661/CTP-656
  • VX-121/tezacaftor/deutivacaftor

Experimental: Cohort 2: Matched Healthy Participants
Healthy participants will receive single dose of VX-121/TEZ/D-IVA.
Drug: VX-121/TEZ/D-IVA
Fixed-dose combination tablets for oral administration.
Other Names:
  • VX-121/VX-661/VX-561
  • VX-121/VX-661/CTP-656
  • VX-121/tezacaftor/deutivacaftor




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, D-IVA, and Relevant Metabolites [ Time Frame: Cohort 1: Pre-dose up to Day 23; Cohort 2: Pre-dose up to Day 13 ]
  2. Area Under the Concentration Versus Time Curve (AUC) of VX-121,TEZ, D-IVA, and Relevant Metabolites [ Time Frame: Cohort 1: Pre-dose up to Day 23; Cohort 2: Pre-Dose up to Day 13 ]
  3. Fraction Unbound (fu) for VX-121 and D-IVA in Plasma [ Time Frame: Cohorts 1 and 2: Pre-dose up to Day 2 ]
  4. Unbound Maximum Observed Concentration (Cmax ub) for VX-121 and D-IVA [ Time Frame: Cohorts 1 and 2: Pre-dose up to Day 2 ]
  5. Unbound Area Under the Concentration Versus Time Curve (AUC ub) of VX-121 and D-IVA [ Time Frame: Cohorts 1 and 2: Pre-dose up to Day 2 ]

Secondary Outcome Measures :
  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Cohort 1: Day 1 up to Day 32; Cohort 2: Day 1 up to Day 17 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Cohort 1: Participants with Moderate Hepatic Impairment

    • Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit
    • Participants will have chronic (≥6 months) documented liver disease
  • Cohort 2: Matched Healthy Participants

    • Participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight

Key Exclusion Criteria:

  • Cohort 1: Participants with Moderate Hepatic Impairment

    • History of febrile illness or other acute illness
    • History of solid organ or bone marrow transplantation
    • History or presence of severe hepatic encephalopathy (Grade >2)
    • Any condition possibly affecting drug absorption
    • Severe portal hypertension
    • Significant renal dysfunction (creatinine clearance <50 milliliter per minute [mL/min] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
  • Cohort 2: Matched Healthy Participants

    • History of febrile illness or other acute illness
    • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05437120


Contacts
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Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

Locations
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United States, Florida
Clinical Pharmacology of Miami, LLC Recruiting
Miami, Florida, United States, 33014-3616
United States, Texas
Endeavor Clinical Trials Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT05437120    
Other Study ID Numbers: VX21-121-008
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases