A Phase 1 Dose Escalation Study of VX-973 in Healthy Participants

NCT06615570 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-973-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

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

  From Day -1 up to Day 30

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

  From Day -1 up to Day 85

Secondary Outcomes (7)

• Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973

  From Day 1 up to Day 30

• Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973

  From Day 1 up to Day 85

• Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973

  From Day 1 up to Day 30

• Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973

  From Day 1 up to Day 85

• Part A: Time Taken for VX-973 to Reach Maximum Concentration (tmax)

  From Day 1 up to Day 30

Study Arms (4)

Part A: Single Ascending Dose

EXPERIMENTAL

Participants will be randomized to receive a single dose of VX-973 under fasted conditions.

Drug: VX-973

Part B: Multiple Ascending Dose

EXPERIMENTAL

Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.

Drug: VX-973

Placebo Part A

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to VX-973.

Drug: Placebo

Placebo Part B

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to VX-973.

Drug: Placebo

Interventions

VX-973 DRUG

Suspension for oral administration.

Part A: Single Ascending Dose; Part B: Multiple Ascending Dose

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 that has not fully resolved within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

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: September 24, 2024
• First Posted: September 26, 2024
• Study Start: September 30, 2024
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)