← Back to Search

Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator

Part A: Sequence 2 for Cystic Fibrosis

Phase 1

Recruiting

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 pre-dose up to 384 hours post-dose

Awards & highlights

Study Summary

"This trial aims to assess how well the granule form of VNZ/TEZ/D-IVA is absorbed in the body compared to other forms, how food affects its absorption, and whether the dosage

Who is the study for?

This trial is for individuals with cystic fibrosis who have a body mass index (BMI) between 18.0 and 32.0 kg/m^2, and weigh more than 50 kg. Specific details on who cannot participate are not provided.Check my eligibility

What is being tested?

The study is testing a granule formulation of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA), focusing on how the body absorbs it, its effects with food, and responses to different doses.See study design

What are the potential side effects?

Potential side effects are not detailed in the information provided but would typically relate to gastrointestinal issues, potential allergic reactions, or other drug-specific concerns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose up to 384 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose up to 384 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 384 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA

Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

+1 more

Secondary outcome measures

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part B: Sequence 2Experimental Treatment1 Intervention

Participants will receive VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.

Group II: Part B: Sequence 1Experimental Treatment1 Intervention

Participants will receive VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.

Group III: Part A: Sequence 3Experimental Treatment1 Intervention

Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 1, then VNZ/TEZ/D-IVA reference FDC tablet in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Group IV: Part A: Sequence 2Experimental Treatment1 Intervention

Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 2, and finally VNZ/TEZ/D-IVA reference FDC tablet in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Group V: Part A: Sequence 1Experimental Treatment1 Intervention

Participants will receive VNZ/TEZ/D-IVA reference fixed dose combination (FDC) tablet in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Do I qualify?Apply below to find out

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

244 Previous Clinical Trials

32,396 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,716 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.

Do I meet the qualifications to participate in this experimental study?

"To be eligible for participation, candidates must have been diagnosed with cystic fibrosis and fall within the age bracket of 18 to 55. The study is open to a maximum of 34 individuals."

Answered by AI

Are patients currently being actively enrolled in this ongoing medical study?

"The ongoing recruitment of participants for this particular investigation is documented on clinicaltrials.gov. The inception date of this study was March 13, 2024, with the most recent update being recorded on March 29, 2024."

Answered by AI

Is the clinical trial open to individuals aged 65 and older?

"Individuals aged between 18 and 55 are eligible for enrollment based on the specified inclusion criteria of this research."

Answered by AI

Has the FDA granted approval for Part A: Sequence 2?

"Based on our assessment at Power, Part A: Sequence 2 has been rated with a safety score of 1. This rating is attributed to the Phase 1 trial nature and the limited available data supporting both efficacy and safety."

Answered by AI

How many participants are currently undergoing treatment in this medical study?

"Indeed, details on clinicaltrials.gov specify that this trial is actively enrolling participants. It was initially posted on March 13th, 2024 and last modified on March 29th, 2024. The research project aims to recruit a total of 34 individuals from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

2024. "A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299709.

All > Phoenix > Paid Studies Glendale