A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Healthy Non-Asian and Japanese Participants

Completed · Phase 1

Conditions studied: Liver Cirrhosis

In brief

This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.

Key facts

Study ID

NCT06715670

Run by

AstraZeneca

People needed

30

Starts

2024-12-05

Expected to finish

2025-02-28

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and female (non-childbearing potential) with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of non-childbearing potential must be confirmed at the Screening Visit.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
• Body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at Screening.
• Japanese participant must have Japanese parents and grandparents, were born in Japan, and not have lived outside Japan for over 10 years.
• Participant is considered non-Asian if their parents and all grandparents are ethnically non-Asian.

You may not qualify if…

• History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis, laboratory values and vital signs at the Screening Visit.
• Any positive result on Screening for serum HBsAg (Hepatitis B surface antigen), HBcAb (Hepatitis B core antibody) or HIV (Human immunodeficiency virus).
• Clinically significant abnormal findings in vital signs after 10 minutes of supine rest.
• Clinically important abnormalities in rhythm, conduction, or morphology of the resting electrocardiography (ECG) and prolonged QTcF > 450 ms, family history of long QT syndrome, or early cardiac death.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• Positive screen for drugs of abuse or alcohol at Screening or first admission.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• Excessive intake of caffeine-containing drinks or food.
• Use of any prescribed or nonprescribed medication, including antacids, analgesics, herbal remedies, mega dose vitamins, and minerals within 2 weeks before the first administration of the study intervention.
• Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months before the Screening Visit.
• Receipt of another new chemical entity within 30 days or 5 half-lives (whichever is longest) of the first administration of the study intervention.
• Previous receipt of zibotentan within 28 days before Day 1 dosing in the Clinical Unit.
• Treatment with strong or moderate Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 28 days or 5 half-lives (whichever is longest) or weak CYP3A4 inhibitors or inducers within 3 days or 3 half-lives (whichever is longest) before dosing.
• Involvement in the planning and/or conduct of the study.
• Ongoing or recent minor medical complaints that may interfere with the interpretation of study data or compliance with study procedures.
• Being vegan or having medical dietary restrictions.
• Inability to communicate reliably with the Principal Investigator or designee.
• Being a vulnerable participant, such as those kept in detention, under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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