A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants

What this trial studies

This study will be conducted in order to determine the effect of repeated oral doses of camizestrant on the pharmacokinetics (PK) of midazolam and to determine the effect of repeated oral titrated doses of carbamazepine on the PK of camizestrant in healthy post-menopausal female participants.

Conditions in scope

• Healthy Participants

Interventions

• Midazolam (Drug) — Midazolam will be administered orally.
• Camizestrant (Drug) — Camizestrant will be administered orally.
• Carbamazepine (Drug) — Carbamazepine will be administered orally.

Who can join

Women only · Ages 50 Years to 70 Years · Accepts healthy volunteers.

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).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2024-08-27
• Primary completion: 2025-08-20
• Last update posted: 2025-09-04
• First posted: 2024-08-09

Sponsor & contact

Lead sponsor: AstraZeneca (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) of midazolam (Period 1 (Day 1) and Period 3 (Day 7 to Day 8))
  To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
• Part A: Area under concentrationcurve from time 0 to the last quantifiable concentration (AUClast) of midazolam (Period 1 (Day 1) and Period 3 (Day 7 to Day 8))
  To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
• Part A: Maximum observed plasma (peak) drug concentration (Cmax) of midazolam (Period 1 (Day 1) and Period 3 (Day 7 to Day 8))
  To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
• Part B: Area under concentration-time curve from time 0 to infinity (AUCinf) of camizestrant (Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25))
  To determine the effect of repeated oral titrated doses of carbamazepine on the PK of a single oral dose of camizestrant in healthy postmenopausal female participants.
• Part B: Area under concentrationcurve from time 0 to the last quantifiable concentration (AUClast) of camizestrant (Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25))
  To determine the effect of repeated oral titrated doses of carbamazepine on the PK of a single oral dose of camizestrant in healthy postmenopausal female participants.

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