CompletedNCT05236543Updated Aug 23, 2022

A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole

A Phase 1 interventional study of AZD4831 and Itraconazole in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-23.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 21
Allocation: Not applicable
Ages: 18 Years to 55 Years
Sex: All

Study summary

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 studied

Healthy Volunteers

Browse trials for

Cardiovascular Diseases 5,025

Keywords

Fixed Sequence Study
Cardiovascular Disease
Drug-drug interaction
Pharmacokinetics
Myeloperoxidase inhibitor

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Experimental
Treatment Arm
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.
Drug: AZD4831 · Drug: Itraconazole

Interventions

DrugAZD4831
Subjects will receive single oral dose only on Day 1 and Day 11.
DrugItraconazole
Subjects will receive Itraconazole orally on Days 8 followed by dosing from Day 9 to Day 17.

What researchers measure

Primary outcomes

Maximum observed plasma (peak) drug concentration (Cmax) for AZD4831
To assess the effect of Itraconazole on AZD4831 only.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Period 1: Study days 1 to 6, 8; Period 3: Study days 11 to 16, 18

Secondary outcomes

Number of subjects with adverse events (AE)
To assess safety and tolerability of AZD4831 alone and in combination with Itraconazole.
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Between Day 25 and Day 32)

Study locations

1 site

Research Site
Harrow, HA1 3UJ, United Kingdom

References and documents

Individual participant data

Plan to share: 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.

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2022 to primary completion in Aug 2022, 5 months.

Of 45 industry-sponsored phase 1 interventional studies under Cardiovascular Diseases, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's 5 months is close to that.

Counting every sponsor, half of 86 studies reached it within 16 months; a quarter within 3 and three quarters within 54.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 2, 2022
First posted: Feb 11, 2022
StartActual: Feb 18, 2022
Primary completionActual: Aug 12, 2022
CompletionActual: Aug 12, 2022
Last update: Aug 23, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05236543
Lead sponsor: AstraZeneca
Collaborators: Parexel
Responsible party: Sponsor
First posted: Feb 11, 2022
Start date: Feb 18, 2022
Primary completion: Aug 12, 2022
Completion: Aug 12, 2022
Last update: Aug 23, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: AZD4831 · Itraconazole

Other studies in this condition

Cardiovascular Diseases →

Other studies from this sponsor

AstraZeneca →

Start the discussion