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Completed

NCT Number: NCT05324410

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

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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Key information

Conditions

APOL1-mediated Kidney Disease

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Lenexa

Lenexa, Kansas, 66219, United States

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:

  • 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.

Treatment and study plan

VX-840

Drug

Solution for oral administration.

Placebo

Drug

Placebo matched to VX-840 for oral administration.

Primary outcomes

  1. 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 outcomes

  1. Parts A and B: Plasma Concentration of VX-840 Over Time

    Time frame: From Day 1 up to Day 14

  2. 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

  3. 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

  4. Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)

    Time frame: From Day 1 up to Day 14

  5. Part B: Associated Renal Clearance (CLr) of VX-840

    Time frame: From Day 1 up to Day 14

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Dec 8, 2022

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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