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NCT05560464 | Completed | Pain

Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment
Sponsor:

Vertex Pharmaceuticals Incorporated

Brief Summary:

The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.

Condition or disease

Pain

Intervention/treatment

VX-548

Phase

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.).}}

Study Type : Interventional
Estimated Enrollment : 36 participants
Masking : None (Open Label)
Primary Purpose : Basic Science
Official Title : A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
Actual Study Start Date : October 14, 2022
Estimated Primary Completion Date : July 24, 2023
Estimated Study Completion Date : July 24, 2023
Arm Intervention/treatment

Experimental: Cohort 1: Mild Hepatic Impairment

Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14.

Drug: VX-548

Experimental: Cohort 2: Matched Healthy Participants

Healthy participants matched to cohort 1 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Drug: VX-548

Experimental: Cohort 3: Moderate Hepatic Impairment

Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Drug: VX-548

Experimental: Cohort 4: Matched Healthy Participants

Healthy participants matched to cohort 3 will receive multiple doses of VX-548 q12h from Day 1 through Day 14.

Drug: VX-548
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Key Inclusion Criteria
  • Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
  • Participants will satisfy the criteria for mild (Cohort 1) and moderate hepatic impairment (Cohort 3) defined as a Child-Pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit
  • Participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease
  • Cohorts 2 and 4: Matched Healthy Participants
  • Participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight
  • Key Exclusion Criteria
    • Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
    • History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
    • Severe portal hypertension
    • History or presence of severe hepatic encephalopathy (Grade >2)
    • Any condition possibly affecting drug absorption
    • Significant renal dysfunction (creatinine clearance <60 milliliter per minute [mL/min] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
    • History of solid organ or bone marrow transplantation
    • Cohorts 2 and 4: Matched Healthy Participants
    • History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
    • Any condition possibly affecting drug absorption
    • Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment

Location Details

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Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Division of Clinical Pharmacology, University of Miami

Miami, florida, United States, 33136

Not yet recruiting

United States, Oklahoma

Orlando Clinical Research Center

Orlando, Oklahoma, United States, 32809