Healthy VolunteersPhase 1NCT05236543
A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole
A Phase 1 study testing AZD4831 and Itraconazole in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD4831 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2022to 12 Aug 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years (inclusive) at the time of signing informed consent, with suitable veins for cannulation or repeated venepuncture.
- Males must be willing to use appropriate contraception methods.
- Females must not be lactating and must be of non-childbearing potential.
- Have a .BMI between 18.5 and 30.0 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.
Who cannot join
- History of any clinically significant disease or disorder, including hyperthyroidism, uncontrolled hypothyroidism or any clinically significant thyroid disease.
- 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
- A positive COVID-19 test at the Screening Visit or admission to the Clinical Unit.
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis, vital signs, and 12-lead ECG.
- Any positive result at the Screening Visit for serum Hepatitis B surface antigen (HBsAg), HCV, and Human immunodeficiency virus (HIV) antibody.
Show all 20Show fewer
- Known or suspected Gilbert's syndrome.
- Known or suspected history of drug abuse in the last 2 years, as judged by the Investigator.
- Has received another new chemical or biological entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study or final follow up visit within 1 month of first administration of IMP in this study.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to the Screening Visit.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4831 or itraconazole.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes).
- Excessive intake of caffeine-containing drinks or foods.
- Known or suspected history of alcohol or excessive intake of alcohol.
- Positive screen for drugs of abuse or cotinine at screening.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed or non prescribed medication including COVID-19 vaccines, antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
- Subjects who have previously received AZD4831.
- Subjects who are lactose intolerant or have other specific dietary restrictions that cannot be accommodated by the Clinical Unit.
- Subjects who, in the opinion of the Investigator, have any clinically significant skin condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole
A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.
Read the detailed description
This will be a an open-label, 3-period fixed sequence study to be conducted at a single study centre.
The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole administration for 3 days (Treatment Period 2) and finally a combination of AZD4831+Itraconazole administration (Treatment Period 3).
The study will comprise of:
- A Screening Period of approximately 28 days.
- Three Treatment Periods:
- Treatment Period 1 (Day -1 through pre-dose Day 8): Single oral dose of AZD4831 only on Day 1,
- Treatment Period 2 (Day 8 through pre-dose Day 11): Oral dose of Itraconazole only on Days 8 through 10,
- Treatment Period 3 (Day 11 through Day 18, after the last PK sample is collected): AZD4831 and Itraconazole on Day 11 and oral dosing of Itraconazole only on Days 12 through 17.
- A final Follow-up Visit after the last PK sample (Day 25 to Day 32).
Each subject will be involved in the study for approximately 9 weeks (including the 28 day Screening Period).
- Conditions
- Healthy Volunteers
- Being tested
- AZD4831, Itraconazole
- Keywords
- Fixed Sequence Study, Cardiovascular Disease, Drug-drug interaction, Pharmacokinetics, Myeloperoxidase inhibitor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4831Drug
Subjects will receive single oral dose only on Day 1 and Day 11.
ItraconazoleDrug
Subjects will receive Itraconazole orally on Days 8 followed by dosing from Day 9 to Day 17.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will receive AZD4831 on Day 1; Itraconazole only on Days 8 through 10 , and AZD4831 and Itraconazole on Day 11 oral dosing of Itraconazole only on Days 12 through 17. Receives: Drug: AZD4831; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma (peak) drug concentration (Cmax) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Time to reach peak or maximum observed concentration or response following drug administration (tmax) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase (Vz/F) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Terminal elimination rate constant (λz) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Measured: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
Secondary outcomes (1)
Number of subjects with adverse events (AE)
To assess safety and tolerability of AZD4831 alone and in combination with Itraconazole.
Measured: From Screening (Day -28 to Day -2) to Follow-up visit (Between Day 25 and Day 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start18 Feb 2022
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT05236543
- Sponsor's protocol ID
- D6580C00013
- Other IDs
- 2021-005727-21
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2022
- Last updated
- 23 Aug 2022
- 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. 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole
- ClinicalTrials.gov ID
- NCT05236543
- Acronym / sponsor ID
- D6580C00013
- Conditions
- Healthy Volunteers
- Keywords
- Fixed Sequence Study, Cardiovascular Disease, Drug-drug interaction, Pharmacokinetics, Myeloperoxidase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 11 Feb 2022 (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.
A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.
Detailed description
This will be a an open-label, 3-period fixed sequence study to be conducted at a single study centre.
The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole administration for 3 days (Treatment Period 2) and finally a combination of AZD4831+Itraconazole administration (Treatment Period 3).
The study will comprise of:
- A Screening Period of approximately 28 days.
- Three Treatment Periods:
- Treatment Period 1 (Day -1 through pre-dose Day 8): Single oral dose of AZD4831 only on Day 1,
- Treatment Period 2 (Day 8 through pre-dose Day 11): Oral dose of Itraconazole only on Days 8 through 10,
- Treatment Period 3 (Day 11 through Day 18, after the last PK sample is collected): AZD4831 and Itraconazole on Day 11 and oral dosing of Itraconazole only on Days 12 through 17.
- A final Follow-up Visit after the last PK sample (Day 25 to Day 32).
Each subject will be involved in the study for approximately 9 weeks (including the 28 day Screening Period).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AZD4831, Drug: ItraconazoleSubjects will receive AZD4831 on Day 1; Itraconazole only on Days 8 through 10 , and AZD4831 and Itraconazole on Day 11 oral dosing of Itraconazole only on Days 12 through 17. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years (inclusive) at the time of signing informed consent, with suitable veins for cannulation or repeated venepuncture.
- Males must be willing to use appropriate contraception methods.
- Females must not be lactating and must be of non-childbearing potential.
- Have a .BMI between 18.5 and 30.0 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.
Key exclusion criteria (20 listed)
- History of any clinically significant disease or disorder, including hyperthyroidism, uncontrolled hypothyroidism or any clinically significant thyroid disease.
- 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 significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
- A positive COVID-19 test at the Screening Visit or admission to the Clinical Unit.
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis, vital signs, and 12-lead ECG.
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 |
|---|---|---|
| AZD4831Subjects will receive single oral dose only on Day 1 and Day 11. | Drug | Treatment Arm |
| ItraconazoleSubjects will receive Itraconazole orally on Days 8 followed by dosing from Day 9 to Day 17. | Drug | Treatment Arm |
Primary outcome
Maximum observed plasma (peak) drug concentration (Cmax) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Time to reach peak or maximum observed concentration or response following drug administration (tmax) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase (Vz/F) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Terminal elimination rate constant (λz) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf) for AZD4831
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18
To assess the effect of Itraconazole on AZD4831 only.
1 secondary outcome
Number of subjects with adverse events (AE)
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Between Day 25 and Day 32)
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 23 Aug 2022.
- 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. 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 shared.
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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 AZD4831 and Itraconazole in people with Healthy Volunteers, 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 5 inclusion and 20 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 23 Aug 2022. 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?
Maximum observed plasma (peak) drug concentration (Cmax) for AZD4831 (time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18). The study lists 9 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 23 Aug 2022.