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A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

Primary Purpose

APOL1-mediated Kidney Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VX-840
Placebo
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for APOL1-mediated Kidney Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Female participants must be of non-childbearing potential
  • Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2)
  • A total body weight greater than (>) 50 kg

Key Exclusion Criteria:

  • History of febrile illness or other acute illness within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • ICON Lenexa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A: VX-840

Part A: Placebo

Part B: VX-840

Part B: Placebo

Arm Description

Participants will be randomized to receive single dose of one of different dose levels of VX-840.

Participants will receive placebo matched to VX-840.

Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.

Participants will receive placebo matched to VX-840.

Outcomes

Primary Outcome Measures

Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Parts A and B: Plasma Concentration of VX-840 Over Time
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
Part B: Associated Renal Clearance (CLr) of VX-840

Full Information

First Posted
April 5, 2022
Last Updated
December 6, 2022
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05324410
Brief Title
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
Official Title
A Phase I, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VX-840 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 in healthy participants.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
APOL1-mediated Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: VX-840
Arm Type
Experimental
Arm Description
Participants will be randomized to receive single dose of one of different dose levels of VX-840.
Arm Title
Part A: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to VX-840.
Arm Title
Part B: VX-840
Arm Type
Experimental
Arm Description
Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to VX-840.
Intervention Type
Drug
Intervention Name(s)
VX-840
Intervention Description
Solution for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to VX-840 for oral administration.
Primary Outcome Measure Information:
Title
Parts A and B: 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 25
Secondary Outcome Measure Information:
Title
Parts A and B: Plasma Concentration of VX-840 Over Time
Time Frame
From Day 1 up to Day 14
Title
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
Time Frame
From Day 1 up to Day 14
Title
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
Time Frame
From Day 1 up to Day 14
Title
Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
Time Frame
From Day 1 up to Day 14
Title
Part B: Associated Renal Clearance (CLr) of VX-840
Time Frame
From Day 1 up to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Female participants must be of non-childbearing potential Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m^2) A total body weight greater than (>) 50 kg Key Exclusion Criteria: History of febrile illness or other acute illness within 14 days before the first dose of study drug Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
ICON Lenexa
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

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