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Completed

A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants

ClinicalTrials.gov ID NCT05653323
Sponsor Vertex Pharmaceuticals Incorporated
Information provided by Vertex Pharmaceuticals Incorporated (Responsible Party)
Last Update Posted 2023-10-12
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Study Overview

Brief Summary
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.
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.).
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-993 in Healthy Adults
Conditions
Pain
Intervention / Treatment
  • Drug: VX-993
  • Drug: Placebo
  • Drug: VX-993
  • Drug: Placebo
Other Study ID Numbers
  • VX22-993-001
  • 2022-002413-42 ( EudraCT Number )
    2022-002413-42 ( EudraCT Number )
Study Start (Actual)
2022-12-14
Primary Completion (Actual)
2023-09-12
Study Completion (Actual)
2023-09-12
Enrollment (Actual)
70
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United Kingdom
Manchester, United Kingdom

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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 within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Sequential Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of different dose levels of VX-993.
Intervention/Treatment Drug: VX-993
  • Suspension for oral administration.

Participant Group/Arm Experimental: Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.
Intervention/Treatment Drug: VX-993
  • Suspension for oral administration.

Participant Group/Arm Placebo Comparator: Placebo Part A
Participants will be randomized to receive placebo matched to VX-993.
Intervention/Treatment Drug: Placebo
  • Suspension for oral administration.

Participant Group/Arm Placebo Comparator: Placebo Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-993.
Intervention/Treatment Drug: Placebo
  • Suspension for oral administration.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 25
Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses Pre-dose up to Day 25
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993 Pre-dose up to Day 25
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 Pre-dose up to Day 25
Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993 Pre-dose up to Day 25
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 Pre-dose up to Day 25
Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test Day 1, Day 10, and Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2022-12-07
First Submitted that Met QC Criteria
2022-12-07
First Posted
2022-12-16
Study Record Updates
Last Update Submitted that met QC Criteria
2023-10-11
Last Update Posted
2023-10-12
Last Verified
2023-10

More Information

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Plan to Share Individual Participant Data (IPD)?
No
IPD 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