VX-407 Safety Study in Healthy Individuals

Recruiting at 1 trial location

Overseen By Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Febrile illness, Drug absorption issues, others

Compensation: Varies

Number of Visits: Unknown

159 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants.

Eligibility Criteria

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.

Inclusion Criteria

I weigh more than 50 kg.

I have not smoked for at least 3 months.

Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)

Exclusion Criteria

I have a condition that might affect how my body absorbs medication.

I have been healthy and fever-free for the last 14 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part A: Single Ascending Dose (SAD)

Participants receive a single dose of different dose levels of VX-407

1 week

Treatment - Part B: Multiple Ascending Dose (MAD)

Participants receive multiple doses of different dose levels of VX-407

4 weeks

Treatment - Part C: Drug-Drug Interaction

Participants are administered Midazolam (MDZ) in the presence or absence of VX-407

2 weeks

Treatment - Part D

Participants receive VX-407 in 1 of 3 treatment sequences with 3 dosing periods to assess the relative bioavailability of VX-407 formulations and the effect of food on pharmacokinetics

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VX-407

Trial Overview 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.

Participant Groups

Group I: Part D Experimental Treatment 1 Intervention

Participants will be randomized to receive VX-407 in 1 of 3 treatment sequences with 3 dosing periods to assess the relative bioavailability of VX-407 formulations and the effect of food on the pharmacokinetics of VX-407.

Group II: Part C: Drug-Drug Interaction Experimental Treatment 2 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 III: Part B: Multiple Ascending Dose (MAD) Experimental Treatment 1 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 IV: Part A: Single Ascending Dose (SAD) Experimental Treatment 1 Intervention

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

Group V: Part B: Placebo Placebo Group 1 Intervention

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

Group VI: Part A: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology