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Completed

NCT Number: NCT07022119

A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 in healthy participants.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

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:

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
  • A total body weight of greater than (>) 50 kg
  • Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

  • History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria will apply.

Treatment and study plan

VX-407

Drug

Suspension for oral administration.

Placebo

Drug

Suspension for oral administration.

Primary outcomes

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Enrollment up to Day 10

  2. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Enrollment up to Day 23

Secondary outcomes

  1. Part A: Maximum Observed Concentration (Cmax) of VX-407 in Plasma

    Time frame: From Day 1 up to Day 6

  2. Part B: Cmax of VX-407 in Plasma

    Time frame: Days 1, 7, and 14 up to Day 19

  3. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma

    Time frame: From Day 1 up to Day 6

  4. Part B: Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-407 in Plasma

    Time frame: Days 1, 7, and 14 up to Day 19

  5. Part A: Time Taken for VX-407 to Reach Maximum Concentration (tmax)

    Time frame: From Day 1 up to Day 6

  6. Part B: Time Taken for VX-407 to Reach Maximum Concentration (tmax)

    Time frame: Days 1, 7, and 14 up to Day 19

  7. Part A: Renal Clearance (CLr) of VX-407

    Time frame: From Day 1 up to Day 6

  8. Part B: CLr of VX-407

    Time frame: Day 1 and Day 14

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Extension Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Mar 27, 2026

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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