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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.