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

Phase 1
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A total body weight of more than 50 kg
Participants of non-childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to test the safety, how well the drug is tolerated, and how the body processes VX-973 in healthy individuals when given either one time or multiple times.

Who is the study for?
This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2 and weight over 50 kg, who are not able to bear children, and have not smoked for at least three months. People can't join if they've been sick with a fever or other illness that hasn't cleared up within two weeks before starting the study, or have conditions that could affect how their body handles drugs.
What is being tested?
The study tests VX-973 against a placebo in healthy participants to see how safe it is and how bodies react to different doses both one-time and over multiple doses. It looks at what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics).
What are the potential side effects?
Since this is an early-phase trial for VX-973, specific side effects aren't listed yet but generally may include reactions where the drug enters the body, changes in appetite, sleep disturbances, mood swings, or any unexpected health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 50 kg.
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I cannot become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Multiple Ascending DoseExperimental Treatment1 Intervention
Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.
Group II: Part A: Single Ascending DoseExperimental Treatment1 Intervention
Participants will be randomized to receive a single dose of VX-973 under fasted conditions.
Group III: Placebo Part APlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-973.
Group IV: Placebo Part BPlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-973.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-973
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
257 Previous Clinical Trials
35,029 Total Patients Enrolled
20 Trials studying Pain
1,331 Patients Enrolled for Pain
~27 spots leftby Oct 2025
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