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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05653323
Collaborator
(none)
90
Enrollment
1
Location
4
Arms
13.6
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 14, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Single Ascending Dose (SAD)

Participants will be randomized to receive a single dose of different dose levels of VX-993.

Drug: VX-993
Suspension for oral administration.
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.

Drug: VX-993
Suspension for oral administration.
Placebo Comparator: Placebo Part A

Participants will be randomized to receive placebo matched to VX-993.

Drug: Placebo
Suspension for oral administration.
Placebo Comparator: Placebo Part B

Participants will be randomized to receive multiple doses of placebo matched to VX-993.

Drug: Placebo
Suspension for oral administration.

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993 [Pre-dose up to Day 25]

  2. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 [Pre-dose up to Day 25]

  3. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993 [Pre-dose up to Day 25]

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 [Pre-dose up to Day 25]

  5. Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test [Day 1, Day 10, and Day 11]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MAC Clinical Research Manchester United Kingdom

Sponsors and Collaborators

  • Vertex Pharmaceuticals Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT05653323
Other Study ID Numbers:
  • VX22-993-001
  • 2022-002413-42
First Posted:
Dec 16, 2022
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Jan 10, 2023