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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VX-121/TEZ/D-IVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05437120

VX21-121-008

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Cohort 1: Moderate Hepatic Impairment

Experimental group

Description:

Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .

Treatment:

Drug: VX-121/TEZ/D-IVA

Cohort 2: Matched Healthy Participants

Experimental group

Description:

Healthy participants will receive single dose of VX-121/TEZ/D-IVA.

Treatment:

Drug: VX-121/TEZ/D-IVA