Phase
Condition
N/ATreatment
Carbamazepine
Camizestrant
Midazolam
Clinical Study ID
Ages 50-70 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy post-menopausal female participants with suitable veins for cannulation orrepeated 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 analternative medical or surgical cause and confirmed by a follicle stimulatinghormone (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 kgand no more than 100 kg inclusive.
Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin Kantagonist anticoagulants) during the study, and for 2 weeks after lastadministration of study intervention.
Exclusion
Exclusion Criteria:
History of any clinically important disease or disorder.
History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof 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 myastheniagravis.
Any clinically important illness, medical/surgical procedure, or trauma within 4weeks of the first administration of study intervention.
Any clinically important abnormalities in clinical chemistry, haematology, orurinalysis results.
Any relevant history or known risk factors of QT prolongation or have received drugsknown 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 ofhypersensitivity to drugs with a similar chemical structure or class to camizestrantor 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 ananticoagulant within 14 days of Screening Visit.
Part B only: Participants identified to carry human leukocyte antigen (HLA)-A3101and/or HLA-B1502 allele.
Participants with bone marrow suppression or a history of bone marrow suppression oraplastic anaemia.
History of or ongoing clinically significant visual disturbances including but notlimited 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 orparticipants who are currently on anticholinergic medications.
Participants with an anticipated need for major surgery and/or any surgery requiringgeneral anaesthesia during the participation in the study.
Vulnerable participants, e.g., kept in detention, protected adults underguardianship, trusteeship, or committed to an institution by governmental orjuridical order.
Study Design
Study Description
Connect with a study center
Research Site
Harrow, HA1 3UJ
United KingdomActive - Recruiting
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