Dilated CardiomyopathyPhase 1NCT06381466
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants.
A Phase 1 study testing AZD0233 in people with Dilated Cardiomyopathy, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- AZD0233
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
- 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 by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
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- Have a body mass index between 18 and 30 kg/m² inclusive and weigh at least 50 kg.
- Note: For Japanese sub-Cohort minimum weight of 45 kg is acceptable.
- For the healthy Japanese sub-Cohorts: healthy Japanese participants (e.g., natives of Japan or Japanese Americans) are defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
Who cannot join
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- 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, hematology, urinalysis, laboratory values or vital signs at Screening and/or first admission to the Clinical Unit.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG that may interfere with the interpretation of corrected QT (QTc) interval changes in heart rate.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to Screening.
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- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- Positive screen for drugs of abuse, or alcohol or cotinine at Screening or on each admission to the Clinical Unit.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs of a similar class to AZD0233.
- Use of drugs with enzyme [Cytochrome P450 3A (CYP3A)]/ transporter [breast cancer resistance protein (BCRP) and organic anion transporting polypeptide 1B (OATP1B)] inducing/ inhibiting properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life. Hormone replacement therapy medications are allowed for female participants.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of investigational medicinal product (IMP) in this study. The period of exclusion begins one month after the final dose.
- Participants who have previously received AZD0233.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever (confirmed tympanic body temperature > 37.6 °C) within 14 days prior to dosing on Day 1 depending on experienced symptoms.
- Clinically significant serious active and chronic infections within 60 days prior to randomization.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Concomitant immunosuppressive and/or steroid treatment.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis C antibody, human immunodeficiency virus (HIV).
- Clinical signs and symptoms consistent with COVID-19.
- Participants who are vegans or have medical dietary restrictions.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the Clinical Unit).
- Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Participants who cannot communicate reliably with the investigator.
- 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, Randomized, Single Blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0233 Following Single and Multiple Ascending Dose Administration in Healthy Male and Female Participants 18 to 50 Years of Age.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants.
Read the detailed description
This is a Phase I, first time in human, single-blinded, randomized, placebo-controlled study in healthy adult male and female (of non-childbearing potential) participants performed at a single Clinical Unit.
The study will be carried out in 2 parts: Part A and Part B. Eight participants will participate in each cohort. Within each cohort, 6 participants will be randomized to receive AZD0233, and 2 participants will be randomized to receive placebo.
Part A of the study will be a sequential SAD design. Five dose levels of AZD0233 are planned to be investigated (dose 1 to dose 5), 2 (dose 3 and dose 4) of which will also be assessed in participants of Japanese descent.
Part A of the study will comprise:
- A Screening Period of maximum 26 days (Day -28 to Day -2).
- An inpatient Period of up to 7 days (Day -1 to Day 6):
- Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A: participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 4 (72 hours after administration of the study intervention).
- Cohort 3A [food effect (FE)]: Participants will be resident at the Clinical Unit from Day -1 before study intervention administration and will check-out on Day 6 (72 hours after administration of the study intervention). The impact of food intake on the PK of AZD0233 will be evaluated in the same participants in Cohort 3A after a 24-hour washout period on Day 2.
Note: Japanese sub-Cohort from Cohort 3A will not be part of the FE study.
- A Follow-up Period of 7 days after the administration of the study intervention which will consist of 1 Follow-up Visit on Day 8 for Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A and one Follow-up Visit on Day 10 for Cohort 3A, for which participants will return to the Clinical Unit for follow-up assessments.
Part B will be a sequential MAD study. Participants will be naïve to AZD0233, i.e., will not have participated in Part A of this study. There will be 3 dose levels in 4 cohorts, including a sub-cohort of participants of Japanese descent at the highest dose.
Part B will consist of:
- A Screening Period of maximum 26 days (Day -28 to Day -2).
- An Inpatient Period of 14 days (Day -1 to Day 13): Participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 13 (>48 hours after administration of the last dose of study intervention in case of QD (once daily) dosing and >36 hours after the last dose for BID (twice a day) in case of dosing).
- A Follow-up Period of 7 days after the administration of the last dose of study intervention which will consist of 2 Follow-up Visits on Day 15 and Day 17.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- AZD0233, AZD0233 Placebo
- Keywords
- Heart failure, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetics
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0233Drug
Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8)
AZD0233 PlaceboDrug
Also called Placebo
Randomized participants will receive matching placebo orally as a SAD or MAD.
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD): Cohort 1A - AZD0233 (dose 1) | Experimental | Healthy participants will receive AZD0233 (dose 1) orally as a single ascending dose. Receives: Drug: AZD0233 |
| Part A (SAD): Cohort 2A - AZD0233 (dose 2) | Experimental | Healthy participants will receive AZD0233 (dose 2) orally as a single ascending dose. Receives: Drug: AZD0233 |
| Part A (SAD): Cohort 3A - AZD0233 (dose 3) | Experimental | Healthy participants will receive AZD0233 (dose 3) orally as a single ascending dose. Receives: Drug: AZD0233 |
| Part A (SAD): Cohort 4A - AZD0233 (dose 4) | Experimental | Healthy participants will receive AZD0233 (dose 4) orally as a single ascending dose. Receives: Drug: AZD0233 |
| Part A (SAD): Cohort 5A - AZD0233 (dose 5) | Experimental | Healthy participants will receive AZD0233 (dose 5) orally as a single ascending dose. Receives: Drug: AZD0233 |
| Part B (MAD): Cohort 1B - AZD0233 (dose 6) | Experimental | Healthy participants will receive AZD0233 (dose 6) orally as a multiple ascending dose. Receives: Drug: AZD0233 |
| Part B (MAD): Cohort 2B - AZD0233 (dose 7) | Experimental | Healthy participants will receive AZD0233 (dose 7) orally as a multiple ascending dose. Receives: Drug: AZD0233 |
| Part B (MAD): Cohort 3B - AZD0233 (dose 8) | Experimental | Healthy participants will receive AZD0233 (dose 8) orally as a multiple ascending dose. Receives: Drug: AZD0233 |
| Part A (SAD): Placebo cohort | Placebo comparator | Healthy participants will receive placebo orally as a single ascending dose. Receives: Drug: AZD0233 Placebo |
| Part B (MAD): Placebo cohort | Placebo comparator | Healthy participants will receive placebo orally as a multiple ascending dose. Receives: Drug: AZD0233 Placebo |
| Part A (SAD): Food Effect (FE) extended Cohort 3A | Experimental | Healthy participants from Cohort 3A will participate in this extended cohort after a washout period of 24 hours. Receives: Drug: AZD0233 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD0233 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) and to estimate the maximum tolerated dose (if within pre-defined exposure limits).
Measured: From screening (Day -28) to follow-up visit (Day 17)
Secondary outcomes (14)
Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233
To characterize the single-dose and steady state pharmacokinetics (PK) of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Terminal elimination half-life (t1/2) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Terminal rate constant (λz) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Accumulation ratio for Cmax (Rac Cmax) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Accumulation ratio for AUC (Rac AUC) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Renal clearance (CLR) of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233
To characterize the single-dose and steady state PK of AZD0233 following oral administration of AZD0233 and to assess the impact of food on the single-dose PK of AZD0233 (Dose 3 FE extended cohort in Cohort 3A of Part A).
Measured: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381466
- Sponsor's protocol ID
- D7250C00001
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single Blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0233 Following Single and Multiple Ascending Dose Administration in Healthy Male and Female Participants 18 to 50 Years of Age.
- ClinicalTrials.gov ID
- NCT06381466
- Acronym / sponsor ID
- D7250C00001
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Heart failure, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Apr 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.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants.
Detailed description
This is a Phase I, first time in human, single-blinded, randomized, placebo-controlled study in healthy adult male and female (of non-childbearing potential) participants performed at a single Clinical Unit.
The study will be carried out in 2 parts: Part A and Part B. Eight participants will participate in each cohort. Within each cohort, 6 participants will be randomized to receive AZD0233, and 2 participants will be randomized to receive placebo.
Part A of the study will be a sequential SAD design. Five dose levels of AZD0233 are planned to be investigated (dose 1 to dose 5), 2 (dose 3 and dose 4) of which will also be assessed in participants of Japanese descent.
Part A of the study will comprise:
- A Screening Period of maximum 26 days (Day -28 to Day -2).
- An inpatient Period of up to 7 days (Day -1 to Day 6):
- Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A: participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 4 (72 hours after administration of the study intervention).
- Cohort 3A [food effect (FE)]: Participants will be resident at the Clinical Unit from Day -1 before study intervention administration and will check-out on Day 6 (72 hours after administration of the study intervention). The impact of food intake on the PK of AZD0233 will be evaluated in the same participants in Cohort 3A after a 24-hour washout period on Day 2.
Note: Japanese sub-Cohort from Cohort 3A will not be part of the FE study.
- A Follow-up Period of 7 days after the administration of the study intervention which will consist of 1 Follow-up Visit on Day 8 for Cohorts 1A, 2A, 3A (Japanese sub-Cohort only), 4A (including a Japanese sub-Cohort), and 5A and one Follow-up Visit on Day 10 for Cohort 3A, for which participants will return to the Clinical Unit for follow-up assessments.
Part B will be a sequential MAD study. Participants will be naïve to AZD0233, i.e., will not have participated in Part A of this study. There will be 3 dose levels in 4 cohorts, including a sub-cohort of participants of Japanese descent at the highest dose.
Part B will consist of:
- A Screening Period of maximum 26 days (Day -28 to Day -2).
- An Inpatient Period of 14 days (Day -1 to Day 13): Participants will be resident at the Clinical Unit from Day -1 before study intervention administration until Day 13 (>48 hours after administration of the last dose of study intervention in case of QD (once daily) dosing and >36 hours after the last dose for BID (twice a day) in case of dosing).
- A Follow-up Period of 7 days after the administration of the last dose of study intervention which will consist of 2 Follow-up Visits on Day 15 and Day 17.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD): Cohort 1A - AZD0233 (dose 1) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 1) orally as a single ascending dose. |
| Part A (SAD): Cohort 2A - AZD0233 (dose 2) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 2) orally as a single ascending dose. |
| Part A (SAD): Cohort 3A - AZD0233 (dose 3) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 3) orally as a single ascending dose. |
| Part A (SAD): Cohort 4A - AZD0233 (dose 4) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 4) orally as a single ascending dose. |
| Part A (SAD): Cohort 5A - AZD0233 (dose 5) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 5) orally as a single ascending dose. |
| Part B (MAD): Cohort 1B - AZD0233 (dose 6) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 6) orally as a multiple ascending dose. |
| Part B (MAD): Cohort 2B - AZD0233 (dose 7) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 7) orally as a multiple ascending dose. |
| Part B (MAD): Cohort 3B - AZD0233 (dose 8) | Experimental | Drug: AZD0233Healthy participants will receive AZD0233 (dose 8) orally as a multiple ascending dose. |
| Part A (SAD): Placebo cohort | Placebo comparator | Drug: AZD0233 PlaceboHealthy participants will receive placebo orally as a single ascending dose. |
| Part B (MAD): Placebo cohort | Placebo comparator | Drug: AZD0233 PlaceboHealthy participants will receive placebo orally as a multiple ascending dose. |
| Part A (SAD): Food Effect (FE) extended Cohort 3A | Experimental | Drug: AZD0233Healthy participants from Cohort 3A will participate in this extended cohort after a washout period of 24 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
- 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 by fulfilling one of the following criteria:
- Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
- Have a body mass index between 18 and 30 kg/m² inclusive and weigh at least 50 kg.
Key exclusion criteria (24 listed)
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- 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, hematology, urinalysis, laboratory values or vital signs at Screening and/or first admission to the Clinical Unit.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG that may interfere with the interpretation of corrected QT (QTc) interval changes in heart rate.
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 |
|---|---|---|
| AZD0233Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) | Drug | Part A (SAD): Cohort 1A - AZD0233 (dose 1), Part A (SAD): Cohort 2A - AZD0233 (dose 2), Part A (SAD): Cohort 3A - AZD0233 (dose 3), Part A (SAD): Cohort 4A - AZD0233 (dose 4), Part A (SAD): Cohort 5A - AZD0233 (dose 5), Part A (SAD): Food Effect (FE) extended Cohort 3A, Part B (MAD): Cohort 1B - AZD0233 (dose 6), Part B (MAD): Cohort 2B - AZD0233 (dose 7), Part B (MAD): Cohort 3B - AZD0233 (dose 8) |
| AZD0233 PlaceboAlso: PlaceboRandomized participants will receive matching placebo orally as a SAD or MAD. | Drug | Part A (SAD): Placebo cohort, Part B (MAD): Placebo cohort |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From screening (Day -28) to follow-up visit (Day 17)
To assess the safety and tolerability of AZD0233 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) and to estimate the maximum tolerated dose (if within pre-defined exposure limits).
14 secondary outcomes
Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Terminal elimination half-life (t1/2) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Terminal rate constant (λz) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Accumulation ratio for Cmax (Rac Cmax) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Accumulation ratio for AUC (Rac AUC) of AZD0233
Time frame: Day 1 (Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2 (24 hours and 36 hours post-dose) and Day 3 (48 hours post-dose)
Renal clearance (CLR) of AZD0233
Time frame: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233
Time frame: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233
Time frame: Spot sample at pre-dose and pooled urine at Day 1 (0-3, 3-6, 6-9, 9-12, and 12-24 hours post-dose), Day 2 (24-36 hours post dose) and Day 3 (36-48 hours post-dose).
Results and safety
The study was stopped early (reason given: The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- 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 AZD0233 in people with Dilated Cardiomyopathy, run by AstraZeneca at 1 site in United States.
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 9 inclusion and 24 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: stopped early, as of the sponsor's last update on 26 Jan 2026. 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 States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The study has been terminated due to adverse finding in a non-clinical, chronic toxicology study.). Results are not available in the source record.
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?
Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: From screening (Day -28) to follow-up visit (Day 17)). 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 26 Jan 2026.