A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

Phase 1

Waitlist Available

Research Sponsored by Vertex Pharmaceuticals Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug called VX-840 to see if it is safe and well-tolerated in healthy people. The study focuses on safety before using the drug in patients who might need it.

Eligible Conditions

Kidney disease

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

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: VX-840Experimental Treatment1 Intervention

Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.

Group II: Part A: VX-840Experimental Treatment1 Intervention

Participants will be randomized to receive single dose of one of different dose levels of VX-840.

Group III: Part A: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matched to VX-840.

Group IV: Part B: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matched to VX-840.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-840

2022