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Completed

NCT Number: NCT05560464

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Division of Clinical Pharmacology, University of Miami, Miami, Florida, United States

Loading trial locations.

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-548

Drug

Tablets for oral administration.

Other names: Suzetrigine

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VX-548

    Time frame: Day 1 to Day 31

  2. Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548

    Time frame: Day 1 to Day 31

  3. Time Taken for VX-548 to Reach Maximum Concentration (tmax)

    Time frame: Day 1 to Day 31

  4. Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)

    Time frame: Day 1 to Day 31

  5. Apparent Volume of Distribution of VX-548 (Vz/F)

    Time frame: Day 1 to Day 31

  6. Apparent Clearance of VX-548 (CL/F)

    Time frame: Day 1 to Day 31

  7. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548

    Time frame: Day 1 to Day 31

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite

    Time frame: Day 1 to Day 31

  2. Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Metabolite

    Time frame: Day 1 to Day 31

  3. Time Taken for VX-548 metabolite to Reach Maximum Concentration (tmax)

    Time frame: Day 1 to Day 31

  4. Time Required for Plasma Concentration of VX-548 Metabolite to Reduce to Half (t1/2)

    Time frame: Day 1 to Day 31

  5. Apparent Volume of Distribution of VX-548 Metabolite (Vz/F)

    Time frame: Day 1 to Day 31

  6. Apparent Clearance of VX-548 Metabolite (CL/F)

    Time frame: Day 1 to Day 31

  7. Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548 Metabolite

    Time frame: Day 1 to Day 31

  8. Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma

    Time frame: Day 14: Up to 24 hours Post-dose

  9. Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite

    Time frame: Day 14: Up to 24 hours Post-dose

  10. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 42

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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