Zibotentan in Healthy Participants

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antacids, Analgesics, Herbal remedies, others

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

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

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

Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria

Clinically significant abnormal findings in vital signs after 10 minutes of supine rest

Excessive intake of caffeine-containing drinks or food

I haven't taken any medication, including over-the-counter drugs and supplements, in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive four different single doses of zibotentan in a cross-over design, with each dose separated by washout periods

4 weeks

4 visits (in-person)

Washout

Washout periods between each treatment dose to ensure no carryover effects

6 days total

Follow-up

Participants are monitored for safety and effectiveness after the final treatment dose

1 week

1 visit (in-person)

Treatment Details

Interventions

• Zibotentan

Trial Overview 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.

Participant Groups

Group I: Treatment sequence DCBA: Zibotentan Experimental Treatment 1 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: Zibotentan Experimental Treatment 1 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: Zibotentan Experimental Treatment 1 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: Zibotentan Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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

Trials

322

Recruited

137,000+

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