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
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
Clinical Pharmacology of Miami, LLC
Miami
GCP Research
St. Petersburg
Time Frame
Start Date: 2022-07-22
Completion Date: 2023-03-16
Participants
Target number of participants: 16
Treatments
Experimental: Cohort 1: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .
Experimental: Cohort 2: Matched Healthy Participants
Healthy participants will receive single dose of VX-121/TEZ/D-IVA.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated