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Completed

NCT Number: NCT05866055

A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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

PAREXEL International

Harrow, United Kingdom

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
  • Participants of non-childbearing potential
  • 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 may apply.

Treatment and study plan

VX-973

Drug

Suspension for oral administration.

Placebo

Drug

Suspension for oral administration.

midazolam

Drug

Syrup 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 31

  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-973

    Time frame: From Day 1 up to Day 30

  2. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973

    Time frame: From Day 1 up to Day 43

  3. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973

    Time frame: From Day 1 up to Day 30

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973

    Time frame: From Day 1 up to Day 43

  5. Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973

    Time frame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose

  6. Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973

    Time frame: Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose

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 VX-973 in Healthy Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
May 6, 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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