Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of C… (NCT05505162) | Clinical Trial Compass
CompletedPhase 1
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
United States24 participantsStarted 2022-08-24
Plain-language 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.
Who can participate
Age range
35 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the protocol.
* Healthy female participants aged 35 to 75 years (inclusive) at Day -1 with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative pregnancy test at screening and within 24 hours prior to dosing with EE/LNG on Day 1 and Day 15, must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling one of the following criteria:
(i) Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range \[FSH \> 40 mIU/mL\].
(ii) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
* Have a body mass index (BMI) between 18.5 and 35 kg/m2 inclusive at Day -1.
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the investigator, 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. Clinically significant diseases or disorders also include, but are not limited to:
(i) Undiagnosed abnormal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under plasma concentration time curve from zero to infinity (AUCinf)
Timeframe: Day 1 and Day 15
2
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
Timeframe: Day 1 and Day 15
3
Maximum observed plasma (peak) drug concentration (Cmax)
Timeframe: Day 1 and Day 15
4
Terminal elimination half-life (t1/2λz)
Timeframe: Day 1 and Day 15
5
Time to reach maximum observed concentration (tmax)
Timeframe: Day 1 and Day 15
6
Apparent total body clearance of drug from plasma (CL/F)
Timeframe: Day 1 and Day 15
7
Apparent volume of distribution based on terminal phase (Vz/F)