VX-407 Safety Study in Healthy Individuals

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 greater than 50 kg

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

"This trial aims to test how safe and well-tolerated VX-407 is in healthy individuals, as well as how the body processes this drug."

Who is the study for?

This trial is for healthy individuals over 50 kg and with a BMI of 18.0 to 32.0 kg/m^2. Participants should be nonsmokers or have quit smoking at least three months prior to screening.

What is being tested?

The study tests VX-407's safety, how well it's tolerated, and how the body processes it (pharmacokinetics). It involves comparing VX-407 against a placebo and Midazolam in healthy participants.

What are the potential side effects?

Specific side effects are not listed but generally may include reactions at the site of administration, potential allergic responses, general discomforts like headaches or nausea, and any unexpected changes in health.

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

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C (Optional): Drug-Drug InteractionExperimental Treatment2 Interventions

Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B.

Group II: Part B: Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention

Participants will be randomized to receive multiple doses of different dose levels of VX-407. The dose levels will be determined based on the data from Part A.

Group III: Part A: Single Ascending Dose (SAD)Experimental Treatment1 Intervention

Participants will be randomized to receive a single dose of different dose levels of VX-407.

Group IV: Part B: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive multiple doses of placebo matched to VX-407.

Group V: Part A: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive placebo matched to VX-407.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018