Zibotentan in Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how the body processes a drug called Zibotentan in healthy individuals. Researchers aim to study the drug's absorption, distribution, metabolism, and elimination in both Non-Asian and Japanese participants. Participants will receive a single dose of Zibotentan on four separate occasions, with breaks in between. A suitable candidate for this trial is a healthy individual with veins appropriate for blood draws who meets specific ethnic criteria, such as Japanese ancestry. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescribed or nonprescribed medications, including antacids, pain relievers, herbal remedies, and vitamins, at least 2 weeks before starting the study.
Is there any evidence suggesting that Zibotentan is likely to be safe for humans?
Research has shown that Zibotentan is generally safe for patients. In earlier studies, no new major safety issues emerged. A small number of patients experienced changes in liver enzymes, indicating possible liver stress. Specifically, 0.4% of patients taking Zibotentan had increased liver enzymes, compared to 0.9% of those taking a placebo. This indicates that safety issues were rare and similar to those in people not taking the drug. Overall, past studies have demonstrated that Zibotentan is safe for most patients.12345
Why do researchers think this study treatment might be promising?
Zibotentan is unique because it targets the endothelin A receptor, which is a different approach compared to the standard treatments for conditions like prostate cancer and other cardiovascular issues. Most traditional options, like chemotherapy or hormone therapies, act broadly or on hormonal pathways. Zibotentan's specific mechanism allows it to potentially block harmful signals that contribute to disease progression, offering a more targeted treatment approach. Researchers are excited because this specificity might reduce side effects and improve outcomes compared to existing therapies.
What evidence suggests that Zibotentan could be effective?
Research has shown how zibotentan moves through the body. Previous studies found that about 58% of zibotentan is excreted through urine. Tests on individuals with moderate liver and kidney issues examined how these conditions affect the drug's processing. In a study on microvascular angina, zibotentan did not alter heart-related markers but did impact blood tests related to the liver, fats, and blood sugar. Although information on its effectiveness for other conditions is limited, these studies provide initial insights into the drug's handling by the body. Participants in this trial will receive zibotentan in different treatment sequences to further explore its pharmacokinetics.16789
Are You a Good Fit for This Trial?
This trial is for healthy non-Asian and Japanese individuals to study how the body processes different doses of Zibotentan, a medication potentially relevant for liver conditions. Specific eligibility details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive four different single doses of zibotentan in a cross-over design, with each dose separated by washout periods
Washout
Washout periods between each treatment dose to ensure no carryover effects
Follow-up
Participants are monitored for safety and effectiveness after the final treatment dose
What Are the Treatments Tested in This Trial?
Interventions
- Zibotentan
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland