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Trial record 1 of 1 for:    VX-634
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A Phase 1, First-in-human Study of VX-634

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05579431
Recruitment Status : Completed
First Posted : October 13, 2022
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Alpha 1-Antitrypsin Deficiency Drug: VX-634 Drug: Placebo Phase 1

Detailed Description:
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.).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-634
Actual Study Start Date : October 13, 2022
Actual Primary Completion Date : May 24, 2023
Actual Study Completion Date : November 13, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
Participants grouped in different cohorts will receive a single ascending dose of VX-634.
 Drug: VX-634
Suspension for oral administration.
Placebo Comparator: Placebo Part A
Participants will be randomized to receive placebo matched to VX-634.
 Drug: Placebo
Suspension for oral administration.
Experimental: Part B
Participants grouped in different cohorts will receive multiple doses of VX-634.The dose levels will be determined based on the data from Part A.
 Drug: VX-634
Suspension for oral administration.
Placebo Comparator: Placebo Part B
Participants will be randomized to receive placebo matched to VX-634.
 Drug: Placebo
Suspension for oral administration.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579431


Locations
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United States, Arizona
Celerion - Tempe
Tempe, Arizona, United States, 85283
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States, 32803
United States, Kansas
ICON Lenexa
Lenexa, Kansas, United States, 66219
United States, Utah
ICON Salt Lake City
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT05579431    
Other Study ID Numbers: VX22-634-001
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes