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Completed

NCT Number: NCT05579431

A Phase 1, First-in-human Study of VX-634

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.

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Key information

Conditions

Alpha 1-Antitrypsin Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Subcutaneous Emphysema

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - Tempe, Tempe, Arizona, United States

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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:

  • Participants of age between 18 to 55 years (inclusive)
  • 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
  • Non smoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

VX-634

Drug

Suspension for oral administration.

Placebo

Drug

Suspension for oral administration.

Primary outcomes

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

    Time frame: Day 1 up to Day 20

Secondary outcomes

  1. Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-634

    Time frame: Day 1 up to Day 20

  2. Part A and B: Area Under the Concentration Versus Time Curve (AUC) of VX-634

    Time frame: Day 1 up to Day 20

  3. Part A and B: Urine Concentration of VX-634

    Time frame: Part A Cohort A3: Days 1 and 5; Part B Cohort B3: Days 1, 10 and 11

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-634

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Mar 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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