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CFTR Modulator

VX-121/TEZ/D-IVA for Cystic Fibrosis

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
Cohort 1: Participants with Moderate Hepatic Impairment
Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1: day 1 up to day 32; cohort 2: day 1 up to day 17
Awards & highlights

Study Summary

This trial looks at the effects of a new drug on people with moderate hepatic impairment, and compares them to healthy people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1: day 1 up to day 32; cohort 2: day 1 up to day 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1: day 1 up to day 32; cohort 2: day 1 up to day 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration Versus Time Curve (AUC) of VX-121,TEZ, D-IVA, and Relevant Metabolites
Fraction Unbound (fu) for VX-121 and D-IVA in Plasma
Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, D-IVA, and Relevant Metabolites
+2 more
Secondary outcome measures
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Matched Healthy ParticipantsExperimental Treatment1 Intervention
Healthy participants will receive single dose of VX-121/TEZ/D-IVA.
Group II: Cohort 1: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezacaftor
FDA approved

Find a Location

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
32,371 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,733 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this research project?

"According to the info hosted on clinicaltrials.gov, this medical study is currently seeking suitable participants; it was initially shared on July 22nd 2022 and most recently updated August 4th 2022."

Answered by AI

What is the current enrollment size for this research endeavor?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical trial began recruitment on July 22nd 2022 and was recently modified on August 4th of the same year. Currently, 24 patients are required to be enrolled between two specific locations."

Answered by AI

Has the FDA granted endorsement of VX-121/TEZ/D-IVA?

"After considering the information available, our experts at Power ranked VX-121/TEZ/D-IVA's safety as a 1. This is due to this being an early Phase 1 medical trial, so there are only limited data points regarding its efficacy and safety profile."

Answered by AI

Who meets the criteria to take part in this medical experiment?

"This medical experiment is enrolling 24 individuals with cystic fibrosis that are between 18 and 70 years of age. The inclusion criteria also stipulates that participants must have a Child-Pugh score ranging from 7 to 9 points, chronic liver disease for at least 6 months, matched smoking habits, similar ages, sexes and weights relative to the hepatic impairment cohort."

Answered by AI

Does this research trial accept participants of a younger age bracket?

"According to the criteria for eligibility, potential participants must be aged between 18 and 70. There are 69 trials that focus on younger patients below 18 years old and 99 specifically targeting those aged 65 or above."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
2022. "Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05437120.
~6 spots leftby Apr 2025
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