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Evaluation of the Pharmacokinetics and Safety of VX 548 in Participants With Severe Renal Impairment

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704556
Collaborator
(none)
18
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe renal impairment and healthy participants.

Condition or Disease Intervention/Treatment 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 Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Severe Renal Impairment and in Matched Healthy Subjects
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Severe Renal Impairment

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

Drug: VX-548
Tablets for oral administration.
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
Tablets for oral administration.

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite [Day 1 to Day 23]

  2. Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 and its Metabolite [Day 1 to Day 23]

Secondary Outcome Measures

  1. Apparent Clearance of VX-548 and its Metabolite (CL/F) [Day 1 to Day 23]

  2. Apparent Renal Clearance of VX-548 and its Metabolite (CLr) [Day 1 to Day 23]

  3. Apparent Non-Renal Clearance of VX-548 and its Metabolite (CLNR/F) [Day 1 to Day 23]

  4. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Day 1 to Day 30]

  5. Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma [Day 1 to Day 23]

  6. Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite [Day 1 to Day 23]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:

  • Cohort 1: Participants with Severe Renal Impairment

  • Body mass index (BMI) of 18.0 to 38.0 kilogram per square meter (kg/m^2)

  • Stable renal function for at least 1 month prior to enrollment, as assessed by the site investigator

  • Cohort 2: Matched Healthy Participants

  • Participants will be matched to Cohort 1 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)

Key Exclusion Criteria:

  • Cohorts 1: Participants with Severe Renal Impairment

  • Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening

  • Cohort 2: Matched Healthy Participants

  • Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis

  • All Cohorts:

  • Participants of childbearing potential

  • History of febrile or 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT05704556
Other Study ID Numbers:
  • VX22-548-014
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Jan 30, 2023