← Back to Search

Endothelin Receptor Antagonist

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

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male and female (non-childbearing potential) with suitable veins for cannulation or repeated venipuncture

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

Must not have

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

Receipt of another new chemical entity within 30 days or 5 half-lives (whichever is longest) of the first administration of the study intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (28 days) to follow-up visit 5 to 7 days post-final dose (approximately 9 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how the body processes Zibotentan in healthy participants from different ethnic backgrounds, including non-Asian and Japanese individuals."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information. However, as with many drugs, there could be risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am healthy with good veins for drawing blood or IV use.

Select...

My BMI is between 18 and 32, and I weigh between 50kg and 100kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I haven't taken any new drugs within the last 30 days or 5 half-lives before starting the study treatment.

Select...

I have not taken zibotentan in the last 28 days.

Select...

I haven't donated blood or lost more than 500 mL of blood in the last 3 months.

Select...

I can communicate clearly with my doctor.

Select...

My heart's electrical activity is normal and I don't have a family history of heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (28 days) to follow-up visit 5 to 7 days post-final dose (approximately 9 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening (28 days) to follow-up visit 5 to 7 days post-final dose (approximately 9 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (28 days) to follow-up visit 5 to 7 days post-final dose (approximately 9 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

Area under concentration-time curve from time 0 to infinity (AUCinf)

Maximum observed drug concentration (Cmax)

Secondary study objectives

Apparent total body clearance (CL/F)

Apparent volume of distribution based on the terminal phase (Vz/F)

Concentration at 24 hours post dose (C24)

+9 more

Side effects data

From 2023 Phase 2 trial • 542 Patients • NCT04724837

Headache

Hypertension

Metabolic acidosis

Brain natriuretic peptide increased

Cardiac failure congestive

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

Zibotentan 0.25 mg + Dapagliflozin

Zibotentan 1.5 mg + Dapagliflozin

Placebo + Dapagliflozin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zibotentan

2019

Completed Phase 2

~810

0 / 8Eligibility criteria met