Healthy ParticipantsPhase 1NCT06547164
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
A Phase 1 study testing Midazolam, Camizestrant and Carbamazepine in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Midazolam, Camizestrant and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2024to 20 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, 2 Part, Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant (AZD9833) on the Pharmacokinetics of Midazolam Exposure (CYP3A4/5 Substrate) and of Carbamazepine (CYP3A4/5 Inducer) on Camizestrant Exposure in Healthy Post Menopausal Female Participants
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.
Read the detailed description
This is an open-label, fixed sequence, 2-part (Part A and Part B), drug-drug interaction study in healthy post-menopausal female participants. Participants enrolled in Part A may subsequently also participate in Part B.
Part A of the study will assess the effect of repeated oral doses of camizestrant on the PK of a single oral dose of midazolam. It will comprise:
- A Screening Period of maximum 28 days.
- Three Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until after the last camizestrant PK sample on Day 8.
- Period 1: participants will receive a single oral dose of midazolam (Day 1).
- Period 2: participants will receive an oral once daily (OD) dose of camizestrant (Day 2 to Day 6).
- Period 3: participants will receive a single oral dose of midazolam and camizestrant (Day 7).
- A Follow-up Visit, for which the participant will return to the Clinical Unit 7 (± 2) days after the last camizestrant PK sample in Period 3.
Part B of the study will assess the effect of multiple oral doses of carbamazepine on the PK of a single oral dose of camizestrant. It will comprise:
- A Screening Period of maximum 28 days.
- Two Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until after the last camizestrant PK sample on Day 16.
- Period 1: participants will receive a single oral dose of camizestrant (Day 1) with PK sampling on Day 1 to Day 4.
- Period 2: participants will receive low oral doses (Dose 1) of carbamazepine twice a day (BID) on Day 4 to Day 6, mid oral doses (Dose 2) of carbamazepine BID on Day 7 to Day 9, and high oral doses (Dose 3) of carbamazepine BID on Day 10 to Day 15. On Day 13, participants will receive a single oral dose of camizestrant.
- A Follow-up Visit, for which the participant will return to the Clinical Unit 7 (± 2) days after the last camizestrant PK sample in Period 2.
- Conditions
- Healthy Participants
- Being tested
- Midazolam, Camizestrant, Carbamazepine
- Keywords
- Midazolam, Camizestrant, Carbamazepine, Post-menopausal, Estrogen receptor (ER) positive disease, Breast Cancer, Cytochrome P450, family 3, subfamily A (CYP3A)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam will be administered orally.
CamizestrantDrug
Also called AZD9833
Camizestrant will be administered orally.
CarbamazepineDrug
Carbamazepine will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Midazolam + Camizestrant | Experimental | Participants will receive a single oral dose of midazolam on Day 1 in Period 1, followed by oral dose of camizestrant OD from Day 2 to Day 6 in Period 2, and then single oral dose of midazolam with camizestrant on Day 7 with PK sampling on Day 7 to Day 8 in Period 3. Receives: Drug: Midazolam; Drug: Camizestrant |
| Part B: Camizestrant + Carbamazepine | Experimental | Participants will receive a single oral dose of camizestrant on Day 1 with PK sampling on Day 1 to Day 4 in Period 1, followed by low oral doses of carbamazepine BID on Day 4 to Day 6, mid oral doses of carbamazepine BID on Day 7 to Day 9 and high oral doses of carbamazepine BID on Day 10 to Day 15 with single oral dose of camizestrant on Day 13 with PK sampling on Day 16 in Period 2. Receives: Drug: Camizestrant; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) of midazolam
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.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Area under concentrationcurve from time 0 to the last quantifiable concentration (AUClast) of midazolam
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.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Maximum observed plasma (peak) drug concentration (Cmax) of midazolam
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.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part B: Area under concentration-time curve from time 0 to infinity (AUCinf) of camizestrant
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.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Area under concentrationcurve from time 0 to the last quantifiable concentration (AUClast) of camizestrant
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.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Maximum observed plasma (peak) drug concentration (Cmax) of camizestrant
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.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Secondary outcomes (12)
Part A: Time to reach maximum observed concentration (tmax) of midazolam
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Terminal elimination half-life (t½λz) of midazolam
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Terminal rate constant (λz) of midazolam
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Apparent total body clearance (CL/F) of midazolam
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Apparent volume of distribution based on the terminal phase (Vz/F) of midazolam
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Plasma concentration of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 3: Pre-dose and 3 hours post-dose of Day 7 and Day 8
Part B: Time to reach maximum observed concentration (tmax) of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Terminal elimination half-life (t½λz) of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Terminal rate constant (λz) of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Apparent total body clearance (CL/F) of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Apparent volume of distribution based on the terminal phase (Vz/F) of camizestrant
To further characterise the effect of camizestrant on the PK of midazolam, and the effect of carbamazepine on the PK of camizestrant, in healthy post-menopausal female participants.
Measured: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To evaluate the safety and tolerability of camizestrant, alone and in combination with midazolam and carbamazepine, respectively, in healthy post-menopausal female participants.
Measured: For SAEs - Part A: From screening (Day -28 to Day -2) to 7 weeks; Part B: From screening (Day -28 to Day -2) to 9 weeks. For AEs: Part A: From Day 1 to 7 weeks; Part B: From Day 1 to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start27 Aug 2024
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547164
- Sponsor's protocol ID
- D8532C00006
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, 2 Part, Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant (AZD9833) on the Pharmacokinetics of Midazolam Exposure (CYP3A4/5 Substrate) and of Carbamazepine (CYP3A4/5 Inducer) on Camizestrant Exposure in Healthy Post Menopausal Female Participants
- ClinicalTrials.gov ID
- NCT06547164
- Acronym / sponsor ID
- D8532C00006
- Conditions
- Healthy Participants
- Keywords
- Midazolam, Camizestrant, Carbamazepine, Post-menopausal, Estrogen receptor (ER) positive disease, Breast Cancer, Cytochrome P450, family 3, subfamily A (CYP3A)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, fixed sequence, 2-part (Part A and Part B), drug-drug interaction study in healthy post-menopausal female participants. Participants enrolled in Part A may subsequently also participate in Part B.
Part A of the study will assess the effect of repeated oral doses of camizestrant on the PK of a single oral dose of midazolam. It will comprise:
- A Screening Period of maximum 28 days.
- Three Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until after the last camizestrant PK sample on Day 8.
- Period 1: participants will receive a single oral dose of midazolam (Day 1).
- Period 2: participants will receive an oral once daily (OD) dose of camizestrant (Day 2 to Day 6).
- Period 3: participants will receive a single oral dose of midazolam and camizestrant (Day 7).
- A Follow-up Visit, for which the participant will return to the Clinical Unit 7 (± 2) days after the last camizestrant PK sample in Period 3.
Part B of the study will assess the effect of multiple oral doses of carbamazepine on the PK of a single oral dose of camizestrant. It will comprise:
- A Screening Period of maximum 28 days.
- Two Treatment Periods during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until after the last camizestrant PK sample on Day 16.
- Period 1: participants will receive a single oral dose of camizestrant (Day 1) with PK sampling on Day 1 to Day 4.
- Period 2: participants will receive low oral doses (Dose 1) of carbamazepine twice a day (BID) on Day 4 to Day 6, mid oral doses (Dose 2) of carbamazepine BID on Day 7 to Day 9, and high oral doses (Dose 3) of carbamazepine BID on Day 10 to Day 15. On Day 13, participants will receive a single oral dose of camizestrant.
- A Follow-up Visit, for which the participant will return to the Clinical Unit 7 (± 2) days after the last camizestrant PK sample in Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Midazolam + Camizestrant | Experimental | Drug: Midazolam, Drug: CamizestrantParticipants will receive a single oral dose of midazolam on Day 1 in Period 1, followed by oral dose of camizestrant OD from Day 2 to Day 6 in Period 2, and then single oral dose of midazolam with camizestrant on Day 7 with PK sampling on Day 7 to Day 8 in Period 3. |
| Part B: Camizestrant + Carbamazepine | Experimental | Drug: Camizestrant, Drug: CarbamazepineParticipants will receive a single oral dose of camizestrant on Day 1 with PK sampling on Day 1 to Day 4 in Period 1, followed by low oral doses of carbamazepine BID on Day 4 to Day 6, mid oral doses of carbamazepine BID on Day 7 to Day 9 and high oral doses of carbamazepine BID on Day 10 to Day 15 with single oral dose of camizestrant on Day 13 with PK sampling on Day 16 in Period 2. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam will be administered orally. | Drug | Part A: Midazolam + Camizestrant |
| CamizestrantAlso: AZD9833Camizestrant will be administered orally. | Drug | Part A: Midazolam + Camizestrant, Part B: Camizestrant + Carbamazepine |
| CarbamazepineCarbamazepine will be administered orally. | Drug | Part B: Camizestrant + Carbamazepine |
Primary outcome
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) of midazolam
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: Maximum observed plasma (peak) drug concentration (Cmax) of camizestrant
Time frame: 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.
12 secondary outcomes
Part A: Time to reach maximum observed concentration (tmax) of midazolam
Time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Terminal elimination half-life (t½λz) of midazolam
Time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Terminal rate constant (λz) of midazolam
Time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Apparent total body clearance (CL/F) of midazolam
Time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Apparent volume of distribution based on the terminal phase (Vz/F) of midazolam
Time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)
Part A: Plasma concentration of camizestrant
Time frame: Period 3: Pre-dose and 3 hours post-dose of Day 7 and Day 8
Part B: Time to reach maximum observed concentration (tmax) of camizestrant
Time frame: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Terminal elimination half-life (t½λz) of camizestrant
Time frame: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Terminal rate constant (λz) of camizestrant
Time frame: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Apparent total body clearance (CL/F) of camizestrant
Time frame: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Part B: Apparent volume of distribution based on the terminal phase (Vz/F) of camizestrant
Time frame: Period 1 (Day 1 to Day 4), Period 2 (Day 22 to Day 25)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: For SAEs - Part A: From screening (Day -28 to Day -2) to 7 weeks; Part B: From screening (Day -28 to Day -2) to 9 weeks. For AEs: Part A: From Day 1 to 7 weeks; Part B: From Day 1 to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam, Camizestrant and Carbamazepine in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) of midazolam (time frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.