A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorpha… (NCT07241065) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
Germany42 participantsStarted 2026-03-19
Plain-language summary
The purpose of this study is to assess the effect of capivasertib on the pharmacokinetics of oral dextromethorphan in healthy participants.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be confirmed at the screening visit (postmenopausal or documentation of irreversible surgical sterilisation).
* Male participants must have documentation of vasectomy done 6 months prior to screening visit. Participants must be willing to use one barrier method of contraception (condom) during sexual intercourse with a female partner of childbearing potential from the time of first study intervention administration until 16 weeks after the last dose of capivasertib.
Main Exclusion Criteria:
* History of any clinically important disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease.
* Any clinically important illness, medical/surgical procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first administration of study intervention or an anticipated need for major surgery during the study.
* Any clinically significant skin abnormalities that are chronic or currently active.
* Abnormal hepato-renal and bone marrow organ function laboratory values.
* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis.
* Any clinically significant abnormalities in glucose metabolism.
* Any positive result …
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 concentration time curve from time 0 to infinity (AUCinf) of dextromethorphan
Timeframe: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8
2
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of dextromethorphan
Timeframe: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8
3
Maximum observed drug concentration (Cmax) of dextromethorphan
Timeframe: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8