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Completed

NCT Number: NCT06226454

A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Salt Lake City

Salt Lake City, Utah, 84124, 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 more than (>) 50 kg
  • Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

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, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

VX-993

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 Day 1 up to Day 16

  2. Part 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 43

Secondary outcomes

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993

    Time frame: Day 1 up to Day 16

  2. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993

    Time frame: Day 1 up to Day 16

  3. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993

    Time frame: Day 1 up to Day 43

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993

    Time frame: Day 1 up to Day 43

  5. Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test

    Time frame: Day 1 up to Day 11

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX-993 in Healthy Adult Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
Jul 12, 2024

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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