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VX-840 for Kidney Disease

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 from day 1 up to day 25
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective.

Eligible Conditions
  • Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to day 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
+2 more

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
Completed Phase 1
~90

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,299 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
2022. "A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05324410.
~29 spots leftby Apr 2025
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