A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Healthy Non-Asian and Japanese Participants
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Trial Summary
What is the purpose of this trial?This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.
Eligibility Criteria
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
I am healthy with good veins for drawing blood or IV use.
My BMI is between 18 and 32, and I weigh between 50kg and 100kg.
Exclusion Criteria
I haven't taken any medication, including over-the-counter drugs and supplements, in the last 2 weeks.
I haven't taken any new drugs within the last 30 days or 5 half-lives before starting the study treatment.
I have not taken zibotentan in the last 28 days.
I haven't donated blood or lost more than 500 mL of blood in the last 3 months.
I can communicate clearly with my doctor.
My heart's electrical activity is normal and I don't have a family history of heart rhythm problems.
Treatment Details
The focus of this study is on measuring blood levels of Zibotentan at four varying oral doses in participants to understand its pharmacokinetics—how the drug is absorbed, distributed, metabolized, and excreted by the body.
4Treatment groups
Experimental Treatment
Group I: Treatment sequence DCBA: ZibotentanExperimental Treatment1 Intervention
Participants will receive single dose of Zibotentan in 4 occassions with first Treatment D, followed by Treatment C, Treatment B and then Treatment A with each dose separated by 3 washout periods.
Group II: Treatment sequence CADB: ZibotentanExperimental Treatment1 Intervention
Participants will receive single dose of Zibotentan in 4 occassions with first Treatment C, followed by Treatment A, Treatment D and then Treatment B with each dose separated by 3 washout periods.
Group III: Treatment sequence BDAC: ZibotentanExperimental Treatment1 Intervention
Participants will receive single dose of Zibotentan in 4 occassions with first Treatment B, followed by Treatment D, Treatment A and then Treatment C with each dose separated by 3 washout periods
Group IV: Treatment sequence ABCD: ZibotentanExperimental Treatment1 Intervention
Participants will receive single dose of Zibotentan in 4 occassions with first Treatment A, followed by Treatment B, Treatment C and then Treatment D with each dose separated by 3 washout periods.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research SiteGlendale, CA
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Who is running the clinical trial?
AstraZenecaLead Sponsor
ParexelIndustry Sponsor