New drug interaction study aims to make camizestrant safer
NCT ID NCT06547164
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed phase 1 study looked at how the experimental cancer drug camizestrant affects the breakdown of midazolam (a sedative) and how carbamazepine (a seizure drug) affects camizestrant levels. Forty healthy postmenopausal women took part. The goal was to gather safety and dosing information, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Camizestrant (AZD9833), midazolam, carbamazepine
- What this could lead to
- If successful, this study will help doctors understand how camizestrant interacts with other drugs, leading to safer dosing recommendations for future patients.
- What could go wrong
- This is an early-phase, small study in healthy volunteers, not patients. Results may not predict effects in people with cancer or those taking other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 70 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy post-menopausal female participants with suitable veins for cannulation or repeated venipuncture. * Female participants must be post-menopausal as confirmed at the Screening Visit. Post-menopausal defined as amenorrhoea for at least 12 months or more without an alternative medical or surgical cause and confirmed by a follicle stimulating hormone (FSH) result of ≥ 30 Internation units/liter (IU/L). * Have a body mass index between 19 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. * Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during the study, and for 2 weeks after last administration of study intervention. Exclusion Criteria: * History of any clinically important disease or disorder. * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * History of any clinically significant cardiovascular, chronic respiratory disease, haematological, neurological or psychiatric disorder. * History of acute pulmonary insufficiency marked neuromuscular respiratory weakness, obsessional states, phobic states, sleep apnoea syndrome, and unstable myasthenia gravis. * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results. * Any relevant history or known risk factors of QT prolongation or have received drugs known to prolong QT interval. * Any positive result for serum Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV). * History of or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to camizestrant or the formulation excipients. * Presence of any contraindication to the probe substrate carbamazepine. * Presence of any contraindication to midazolam. * Have any active indication for therapeutic anticoagulation, and/or having taken an anticoagulant within 14 days of Screening Visit. * Part B only: Participants identified to carry human leukocyte antigen (HLA)-A\*3101 and/or HLA-B\*1502 allele. * Participants with bone marrow suppression or a history of bone marrow suppression or aplastic anaemia. * History of or ongoing clinically significant visual disturbances including but not limited to visual hallucinations, migraine with visual symptoms, blurred vision, frequent floaters/flashes associated with other symptoms such as dizziness. * Participants with family history of glaucoma or closed angle glaucoma or participants who are currently on anticholinergic medications. * Participants with an anticipated need for major surgery and/or any surgery requiring general anaesthesia during the participation in the study. * Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Harrow, HA1 3UJ, United Kingdom
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