A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Health… (NCT06715670) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Healthy Non-Asian and Japanese Participants
United States30 participantsStarted 2024-12-05
Plain-language summary
This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 cl…
What they're measuring
1
Area under concentration-time curve from time 0 to infinity (AUCinf)
Timeframe: Day 1 through Day 3 of each Treatment Period (each Treatment Period is 7 days)
2
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Timeframe: Day 1 through Day 3 of each Treatment Period (each Treatment Period is 7 days)
3
Maximum observed drug concentration (Cmax)
Timeframe: Day 1 through Day 3 of each Treatment Period (each Treatment Period is 7 days)