Zibotentan and EE/LNG for Healthy Female Participants

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Brooklyn, MD
Healthy Female Participants
Zibotentan - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

A study to assess the Pharmacokinetics (PK) of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG) in healthy female participants of non-child-bearing potential, when administered alone and in combination with multiple oral doses of zibotentan.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Day 1 and Day 15

Day 15
Apparent total body clearance of drug from plasma (CL/F)
Apparent volume of distribution based on terminal phase (Vz/F)
Area under plasma concentration time curve from zero to infinity (AUCinf)
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
Terminal elimination half-life (t1/2λz)
Day 15
Area under plasma concentration-time curve in the dose interval (AUCtau)
Maximum observed plasma (peak) drug concentration (Cmax)
Time to reach maximum observed concentration (tmax)
Day 7
Number of participants with adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Zibotentan and EE/LNG
1 of 1
Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: Zibotentan and EE/LNG · No Placebo Group · Phase 1

Zibotentan and EE/LNGExperimental Group · 2 Interventions: Zibotentan, EE/LNG · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zibotentan
2021
Completed Phase 1
~20

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and day 15
Closest Location: Research Site · Brooklyn, MD
1900First Recorded Clinical Trial
1 TrialsResearching Healthy Female Participants
2948 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are capable of giving informed consent.
You have a body mass index (BMI) between 18.5 and 35 kg/m2 inclusive at Day 0.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.