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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2022-11-07

Brief Summary

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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.

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Detailed Description

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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.).

Conditions

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APOL1-mediated Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: VX-840

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

Group Type EXPERIMENTAL

VX-840

Intervention Type DRUG

Solution for oral administration.

Part A: Placebo

Participants will receive placebo matched to VX-840.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to VX-840 for oral administration.

Part B: 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.

Group Type EXPERIMENTAL

VX-840

Intervention Type DRUG

Solution for oral administration.

Part B: Placebo

Participants will receive placebo matched to VX-840.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to VX-840 for oral administration.

Interventions

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VX-840

Solution for oral administration.

Intervention Type DRUG

Placebo

Placebo matched to VX-840 for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes