VNZ/TEZ/D-IVA and Rosuvastatin Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the drug combination Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) interacts with rosuvastatin, a common cholesterol medication. Researchers aim to determine the safety and interaction of these drugs when taken together. The trial suits individuals who are generally healthy, weigh over 50 kg, and have no recent illnesses that could impact the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination treatment of vanzacaftor, tezacaftor, and deutivacaftor, known as VNZ/TEZ/D-IVA, is generally safe. Previous studies found that similar drugs, such as tezacaftor and ivacaftor, do not significantly alter drug metabolism. As a result, VNZ/TEZ/D-IVA is usually well-tolerated. Although some interactions with other drugs and food exist, proper guidance can manage these. Overall, the treatment is considered safe, but participants must follow trial instructions and report any side effects to ensure safety.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about VNZ/TEZ/D-IVA because it combines three active ingredients—Vanzacaftor, Tezacaftor, and Deutivacaftor—in a single treatment, potentially offering a more comprehensive approach for treating cystic fibrosis. Unlike existing treatments that typically focus on just one or two components, this combination targets multiple underlying causes of the disease, which may improve lung function and reduce symptoms more effectively. Additionally, the co-administration with Rosuvastatin could enhance the treatment's efficacy, making it a promising new option in the fight against cystic fibrosis.
What evidence suggests that VNZ/TEZ/D-IVA might be an effective treatment for its intended use?
Research has shown that the combination of vanzacaftor, tezacaftor, and deutivacaftor (VNZ/TEZ/D-IVA) can improve lung function in people with cystic fibrosis. In earlier studies, patients who took VNZ/TEZ/D-IVA experienced significantly better lung function than those who did not. For instance, one study found that patients were almost three times more likely to see improvement. This combination addresses specific protein issues common in cystic fibrosis, aiding breathing and reducing flare-ups. In this trial, participants will receive VNZ/TEZ/D-IVA alongside rosuvastatin to study their interaction. Current evidence suggests that VNZ/TEZ/D-IVA holds promise for managing cystic fibrosis.15678
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a BMI of 18.0 to 32.0 kg/m^2 and weighing over 50 kg. It's not specified who can't join, but typically those with health conditions affecting drug metabolism or conflicting medications would be excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Rosuvastatin is administered as a single oral dose on Day 1, followed by co-administration with VNZ/TEZ/D-IVA from Day 18. VNZ/TEZ/D-IVA is administered once daily from Day 5 to Day 22.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA)
Trial Overview
The study is testing how multiple doses of VNZ/TEZ/D-IVA affect the body's handling (pharmacokinetics) of rosuvastatin, a cholesterol-lowering medication, as well as the safety of taking these drugs together.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Rosuvastatin will be administered to participants as a single oral dose on Day 1 and then co-administered with VNZ/TEZ/D-IVA on Day 18.VNZ/TEZ/D-IVA dose will be administered once daily (qd) from Day 5 to Day 22.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
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
Citations
Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D ...
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the ...
2.
ctv.veeva.com
ctv.veeva.com/study/effect-of-vanzacaftor-tezacaftor-deutivacaftor-vnz-tez-d-iva-on-the-pk-of-rosuvastatin-in-healthyEffect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA ...
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of ...
Vanzacaftor-Tezacaftor-Deutivacaftor (Alyftrek) - NCBI Bookshelf
The 24-week pooled outcome including data from both the SKYLINE 102 and SKYLINE 103 trials reported an odds ratio of 2.87 (95% CI, 2.00 to 4.12; P < 0.0001), ...
SwissPAR - Alyftrek
Interactions with medicinal products. CYP3A inducers. Exposures to vanzacaftor (VNZ), tezacaftor (TEZ) and deutivacaftor (D-IVA) are expected to.
Effect-of-VanzacaftorTezacaftorDeutivacaftor-VNZTEZDIVA ...
rosuvastatin - Generic mfg. Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) - Vertex. http://clinicaltrials.gov/ct2/show/NCT07349394. Jan 17 ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/d774ade9395959e6/nct07349394-vanzacaftor-tezacaftor-deutivacaftor-rosuvastatin-interaction-studyEffect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA ...
The study is being conducted to evaluate the effect of multiple doses of VNZ/TEZ/D-IVA on the PK of rosuvastatin and the safety and tolerability of ...
Drug Interactions
Interaction between tezacaftor/ivacaftor and ivacaftor alone has been studied and were found to have no clinically relevant effect on the exposures of the oral ...
Deutivacaftor/tezacaftor/vanzacaftor Interactions
There are 247 drugs known to interact with deutivacaftor/tezacaftor/vanzacaftor, along with 2 disease interactions, and 3 alcohol/food interactions. Of the ...
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