VX-828 for Cystic Fibrosis

Overseen By Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Febrile illness, Drug absorption issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.

Eligibility Criteria

This trial is for individuals with a BMI of 18.0 to 32.0 kg/m^2, weighing over 50 Kg, who are nonsmokers or have quit smoking for at least 3 months. It's aimed at those not capable of childbearing and suffering from Cystic Fibrosis or related liver disease.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

I weigh more than 50 Kg.

I have not smoked for at least 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VX-828 in either tablet or suspension form to evaluate relative bioavailability

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after receiving the study drug

2 weeks

Treatment Details

Interventions

• VX-828

Trial Overview The study is testing the new drug VX-828 in tablet form to see how it's absorbed by the body compared to its liquid form and checking if it's safe and doesn't cause any problems when taken.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of VX-828 tablets.

Group II: Cohort 1 Active Control 1 Intervention

Participants will be randomized to receive a single dose of VX-828 suspension.

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