Healthy volunteers help scientists understand zibotentan's body journey
NCT ID NCT06715670
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug zibotentan is absorbed and cleared by the body in 30 healthy adults, including both non-Asian and Japanese participants. It was a phase 1 trial, meaning it was an early step to gather safety and drug-level information. The study did not aim to treat any disease, so there was no direct health benefit for volunteers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Glendale, California, 91206, United States
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