VX-993 and Metformin for Pain

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

Key

* A total body weight of more than (\>) 50 Kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well a new drug, VX-993, works with the commonly used medication metformin in healthy individuals. The study will look at how the drugs interact in the body

Who is the study for?

This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2, weighing over 50 Kg, and who are nonsmokers or have quit smoking for at least three months before starting the study.

What is being tested?

The study is testing how VX-993 and Metformin affect each other when taken together by healthy people. It looks at the drug levels in the body, safety, and how well participants can tolerate them.

What are the potential side effects?

Possible side effects from taking VX-993 and Metformin together may include digestive issues like nausea or diarrhea, headaches, dizziness, or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh more than 50 Kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VX-993 and MetforminExperimental Treatment2 Interventions

Metformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-993

2024

Completed Phase 1

~180

Metformin

2006

Completed Phase 4

~2430