VX-828 Safety Study

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Transplantation, Cirrhosis, Lung infection, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

225 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying a new medicine called VX-828 in healthy people to see if it is safe and how the body handles it.

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 or your doctor.

Eligibility Criteria

This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2 and weighing over 50 kg. Participants should be nonsmokers or ex-smokers who quit at least 3 months prior, confirmed by tests.

Inclusion Criteria

I weigh more than 50 kg.

You have not smoked for at least 3 months before the screening, and a test will be done to confirm that you are currently not smoking.

Your body mass index (BMI) is between 18.0 and 32.0.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VX-828 in various combinations and dosages, including single ascending dose, multiple ascending dose, and drug-drug interaction studies

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term in an open-label cohort

Treatment Details

Interventions

• VX-828

Trial Overview The study is testing VX-828's safety, how well it's tolerated, and its pharmacokinetics (how the drug moves through the body). It involves comparing VX-828 with Midazolam (a control drug), Itraconazole (to check interactions), and a placebo.

Participant Groups

Group I: Part E: VX-828 in Triple Combination (TC) with TEZ/VX-118 in CF Experimental Treatment 3 Interventions

Participants with cystic fibrosis will receive VX-828 in TC with TEZ/VX-118.

Group II: Part D: VX-828 in Triple Combination (TC) with TEZ/VX-118 Experimental Treatment 3 Interventions

Participants will be randomized to receive VX-828 in TC with TEZ/VX-118.

Group III: Part C: Drug Drug Interaction Experimental Treatment 5 Interventions

Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828/TEZ/VX-118 administration, and concomitant administration of VX-828/TEZ/VX-118 and Midazolam. Part C will be an open-label optional cohort.

Group IV: Part B: Multiple Ascending Dose (MAD) Experimental Treatment 1 Intervention

Participants will be randomized to receive multiple doses of different dose levels of VX-828. The dose levels will be determined based on the data from Part A.

Group V: 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-828.

Group VI: Part D: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to VX-828 in TC with TEZ/VX-118.

Group VII: Part A: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to VX-828.

Group VIII: Part B: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive placebo matched to VX-828.

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