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

NCT05653323 | Completed Phase 1 FDA Drug

• 2 other identifiers: VX22-993-0012022-002413-42
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (4)

Part A: Single Ascending Dose (SAD)

EXPERIMENTAL

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

Drug: VX-993

Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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

Placebo Part A

PLACEBO COMPARATOR

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

Drug: Placebo

Placebo Part B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VX-993 DRUG

Suspension for oral administration.

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD)

Placebo DRUG

Suspension for oral administration.

Placebo Part A; Placebo Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of febrile illness or other acute illness within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: December 14, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)