Status:
COMPLETED
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 heal...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05437120
Start Date
July 22 2022
End Date
March 16 2023
Last Update
March 30 2023
Active Locations (2)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014-3616
2
GCP Research
St. Petersburg, Florida, United States, 33705