Cardiovascular DiseasePhase 1NCT02712372

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of AZD4831 in Healthy Male Subjects

A Phase 1 study testing AZD4831 in people with Cardiovascular Disease, run by AstraZeneca.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a Phase I, first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single and multiple ascending doses in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease
What is being tested?: AZD4831
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: No sites listed yet
Study dates: Jun 2016to Oct 2016
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent before any study specific procedures.
Healthy male subjects aged 18 - 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg inclusive.
Provision of signed, written and dated informed consent for optional genetic/biomarker research.
Subjects must be able to read, speak and understand the German language.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Presence of infection(s) (particularly fungal infection), as judged by the investigator.
History or current thyroid disease.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator.

Show all 31Show fewer

Any positive result on screening for serum hepatitis B surface antigen (HBsAg), anti-hepatitis B core (anti-HBc) antibodies, hepatitis C antibody and human immunodeficiency virus (HIV).
Abnormal vital signs
Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or LV hypertrophy.
Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome.
PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation)
PR (PQ) interval prolongation (> 200 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation
Persistent or intermittent complete bundle branch block, incomplete bundle branch block, or intraventricular conduction delay with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation.
ECG findings suggesting a metabolic or other non-cardiac condition that may confound interpretation of serial changes (such as hypokalemia).
Known or suspected history of drug abuse, as judged by the investigator.
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of alcohol abuse or excessive intake of alcohol, as judged by the investigator.
Positive screen for drugs of abuse, cotinine (nicotine) or alcohol at screening or admission to the unit before the first administration of IMP.
History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4831.
Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.
Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks before the first administration of IMP.
Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks before the first administration of IMP or longer if the medication has a long half-life.
Plasma donation within 1 month of screening or any blood donation/blood loss > 500 mL during the 3 months before screening.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest.
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Involvement of any Astra Zeneca, PAREXEL or study site employee or their close relatives.
Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., 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.
Subjects who are vegans or have medical dietary restrictions.
Subjects who cannot communicate reliably with the investigator.
Previous bone marrow transplant.
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.

About this study

Official title: A Phase I, Randomised, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4831 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects

Read the detailed description

This is a Phase I, FIH, randomized, single-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single (Part 1) and multiple (Part 2) ascending doses in healthy male subjects. The study will be conducted at a single study center with a planned number of subjects of up to 125 healthy males, aged 18 to 50 years.

Conditions: Cardiovascular Disease
Being tested: AZD4831, AZD4831 placebo
Keywords: AZD4831 oral suspension, Healthy male subjects, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
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
AZD4831 1-50 mg/g oral suspension
AZD4831 placeboDrug
AZD4831 placebo oral suspension

Study groups in NCT02712372
Study group	Role	What they receive
Part 1, Dose Level 1	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 1, Dose Level 2	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 1, Dose Level 3	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 1, Dose Level 4	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 1, Dose Level 5	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 1, Dose Level 6	Experimental	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Receives: Drug: AZD4831
Part 2, Dose Level 1	Experimental	Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12 Receives: Drug: AZD4831
Part 2, Dose Level 2	Experimental	Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12 Receives: Drug: AZD4831
Part 2, Dose Level 3	Experimental	Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12 Receives: Drug: AZD4831
AZD4831 Placebo	Placebo comparator	Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12 Receives: Drug: AZD4831 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequencies of adverse events
To assess the safety and tolerability of single and multiple doses of AZD4831
Measured: From screening up to 10 days post final dose
Supine blood pressure (Part 1)
To assess change from baseline in supine blood pressure
Measured: From screening up to 48 hours post dose
Supine pulse rate (Part 1)
To assess change from baseline in supine pulse rate
Measured: From screening up to 48 hours post dose
Supine body temperature (Part 2)
To assess change from baseline in supine body temperature
Measured: From screening up to pre-dose Day 12
12-lead electrocardiogram
To assess 12-lead electrocardiogram
Measured: From screening up to 10 days post final dose
12-lead electrocardiogram (cardiac telemetry)
12-lead electrocardiogram (cardiac telemetry)
Measured: From Day-1 up to 24 hours post final dose
Physical examination
To assess subject through a physical examination, including assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Measured: From screening up to 10 days post final dose
To assess the subject through hematology laboratory assessment
To assess a subject through hematology laboratory assessment
Measured: From screening up to 10 days post final dose
Percentage of adverse events
To assess the safety and tolerability of single and multiple doses of AZD4831
Measured: From screening to 10 days post final dose
Supine blood pressure (Part 2)
To assess change from baseline in supine blood pressure
Measured: From screening up to 10 days post final dose
Supine pulse rate (Part 2)
To assess change from baseline in supine pulse rate
Measured: From screening up to 10 days post final dose
Chemistry evaluations
including high-sensitivity C-reactive protein {hs-CRP} and thyroid panel
Measured: From screening up to 10 days post final dose
To assess the subject through urinalysis laboratory assessment
To assess a subject through urinalysis laboratory assessment
Measured: From screening up to 10 days post final dose

Secondary outcomes (22)

Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Time to reach maximum plasma concentration, taken directly from the individual concentration-time curve (tmax)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Terminal half-life, estimated as (ln2)/λz (t1/2λz)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve over 24 hours (AUCτ)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Mean Residence Time (MRT)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Apparent volume of distribution for parent drug at terminal phase (Vz/F)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUC0-t/D)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Observed maximum plasma concentration divided by the dose administered (Cmax/D)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve over the dosing interval divided by the dose administered (AUCτ/D) (Part 2 only)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post final dose
Accumulation ratio calculated as AUCτ Day 12/ AUCτ Day 1 (Rac AUC) (Part 2 only)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post final dose
Accumulation ratio calculated as Cmax Day 12/ Cmax Day 1 (Rac Cmax) (Part 2 only)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post final dose
Temporal change parameter in systemic exposure (TCP) (Part 2 only)
To characterize the plasma pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post final dose
Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]
Assessment of the urine PK following single and multiple doses of pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Cumulative amount of analyte excreted at time t [Ae(0-t)]
Assessment of the urine PK following single and multiple doses of pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Fraction of dose excreted unchanged into the urine from time t1 to t2, estimated by dividing Ae(t1-t2) by dose [fe(t1-t2)]
Assessment of the urine PK following single and multiple doses of pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Fraction of dose excreted unchanged into the urine from time zero to time t, estimated by dividing Ae(0-t) by dose [fe(0-t)]
Assessment of the urine PK following single and multiple doses of pharmacokinetics of AZD4831
Measured: From pre-dose up to 48 hours post dose
Renal clearance, estimated by dividing Ae(0-t) by AUC(0-t) (CLR)
Assessment of the urine PK following single and multiple doses of pharmacokinetics of AZD4831
Measured: From pre-dose up to 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.

Jun 2016Oct 2016

First posted18 Mar 2016 (estimated)
Study startJun 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02712372
Sponsor's protocol ID: D6580C00001
Status last verified: Jan 2017
First submitted: 15 Mar 2016
Last updated: 6 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Sunnaker M, Leander J, Ericsson H. Population Pharmacokinetics of the Novel Myeloperoxidase Inhibitor Mitiperstat. Pharmacol Res Perspect. 2026 Jun;14(3):e70259. doi: 10.1002/prp2.70259.
PubMed 42101107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4831 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
ClinicalTrials.gov ID: NCT02712372
Acronym / sponsor ID: D6580C00001
Conditions: Cardiovascular Disease
Keywords: AZD4831 oral suspension, Healthy male subjects, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 104 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 18 Mar 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 10

Arm	Type	Receives
Part 1, Dose Level 1	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 1, Dose Level 2	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 1, Dose Level 3	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 1, Dose Level 4	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 1, Dose Level 5	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 1, Dose Level 6	Experimental	Drug: AZD4831Part 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions.
Part 2, Dose Level 1	Experimental	Drug: AZD4831Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12
Part 2, Dose Level 2	Experimental	Drug: AZD4831Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12
Part 2, Dose Level 3	Experimental	Drug: AZD4831Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12
AZD4831 Placebo	Placebo comparator	Drug: AZD4831 placeboPart 1: Part 1A: Single dose administered in the morning on Day 1 under fasted conditions. Part 1B: Single dose administered in the morning of Day 1 under fed conditions. Part 2: Single dose administered in the morning on Day 1 and multiple doses administered once daily, in the morning, Days 3 to 12

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Provision of signed and dated, written informed consent before any study specific procedures.
Healthy male subjects aged 18 - 50 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg inclusive.
Provision of signed, written and dated informed consent for optional genetic/biomarker research.
Subjects must be able to read, speak and understand the German language.

Key exclusion criteria (31 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Presence of infection(s) (particularly fungal infection), as judged by the investigator.
History or current thyroid disease.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).

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
AZD4831AZD4831 1-50 mg/g oral suspension	Drug	Part 1, Dose Level 1, Part 1, Dose Level 2, Part 1, Dose Level 3, Part 1, Dose Level 4, Part 1, Dose Level 5, Part 1, Dose Level 6, Part 2, Dose Level 1, Part 2, Dose Level 2, Part 2, Dose Level 3
AZD4831 placeboAZD4831 placebo oral suspension	Drug	AZD4831 Placebo

Primary outcome

Frequencies of adverse events
Time frame: From screening up to 10 days post final dose
To assess the safety and tolerability of single and multiple doses of AZD4831
Supine blood pressure (Part 1)
Time frame: From screening up to 48 hours post dose
To assess change from baseline in supine blood pressure
Supine pulse rate (Part 1)
Time frame: From screening up to 48 hours post dose
To assess change from baseline in supine pulse rate
Supine body temperature (Part 2)
Time frame: From screening up to pre-dose Day 12
To assess change from baseline in supine body temperature
12-lead electrocardiogram
Time frame: From screening up to 10 days post final dose
To assess 12-lead electrocardiogram
12-lead electrocardiogram (cardiac telemetry)
Time frame: From Day-1 up to 24 hours post final dose
12-lead electrocardiogram (cardiac telemetry)
Physical examination
Time frame: From screening up to 10 days post final dose
To assess subject through a physical examination, including assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
To assess the subject through hematology laboratory assessment
Time frame: From screening up to 10 days post final dose
To assess a subject through hematology laboratory assessment
Percentage of adverse events
Time frame: From screening to 10 days post final dose
To assess the safety and tolerability of single and multiple doses of AZD4831
Supine blood pressure (Part 2)
Time frame: From screening up to 10 days post final dose
To assess change from baseline in supine blood pressure
Supine pulse rate (Part 2)
Time frame: From screening up to 10 days post final dose
To assess change from baseline in supine pulse rate
Chemistry evaluations
Time frame: From screening up to 10 days post final dose
including high-sensitivity C-reactive protein {hs-CRP} and thyroid panel
To assess the subject through urinalysis laboratory assessment
Time frame: From screening up to 10 days post final dose
To assess a subject through urinalysis laboratory assessment

22 secondary outcomes

Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
Time frame: From pre-dose up to 48 hours post dose
Time to reach maximum plasma concentration, taken directly from the individual concentration-time curve (tmax)
Time frame: From pre-dose up to 48 hours post dose
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time frame: From pre-dose up to 48 hours post dose
Terminal half-life, estimated as (ln2)/λz (t1/2λz)
Time frame: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve over 24 hours (AUCτ)
Time frame: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)
Time frame: From pre-dose up to 48 hours post dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: From pre-dose up to 48 hours post dose
Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)
Time frame: From pre-dose up to 48 hours post dose
Mean Residence Time (MRT)
Time frame: From pre-dose up to 48 hours post dose
Apparent volume of distribution for parent drug at terminal phase (Vz/F)
Time frame: From pre-dose up to 48 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUC0-t/D)
Time frame: From pre-dose up to 48 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
Time frame: From pre-dose up to 48 hours post dose
Observed maximum plasma concentration divided by the dose administered (Cmax/D)
Time frame: From pre-dose up to 48 hours post dose
Area under the plasma concentration-curve over the dosing interval divided by the dose administered (AUCτ/D) (Part 2 only)
Time frame: From pre-dose up to 48 hours post final dose
Accumulation ratio calculated as AUCτ Day 12/ AUCτ Day 1 (Rac AUC) (Part 2 only)
Time frame: From pre-dose up to 48 hours post final dose
Accumulation ratio calculated as Cmax Day 12/ Cmax Day 1 (Rac Cmax) (Part 2 only)
Time frame: From pre-dose up to 48 hours post final dose
Temporal change parameter in systemic exposure (TCP) (Part 2 only)
Time frame: From pre-dose up to 48 hours post final dose
Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]
Time frame: From pre-dose up to 48 hours post dose
Cumulative amount of analyte excreted at time t [Ae(0-t)]
Time frame: From pre-dose up to 48 hours post dose
Fraction of dose excreted unchanged into the urine from time t1 to t2, estimated by dividing Ae(t1-t2) by dose [fe(t1-t2)]
Time frame: From pre-dose up to 48 hours post dose
Fraction of dose excreted unchanged into the urine from time zero to time t, estimated by dividing Ae(0-t) by dose [fe(0-t)]
Time frame: From pre-dose up to 48 hours post dose
Renal clearance, estimated by dividing Ae(0-t) by AUC(0-t) (CLR)
Time frame: From pre-dose up to 48 hours post dose

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Derived from this study: PubMed 42101107Sunnaker M, Leander J, Ericsson H. Population Pharmacokinetics of the Novel Myeloperoxidase Inhibitor Mitiperstat. Pharmacol Res Perspect. 2026 Jun;14(3):e70259. doi: 10.1002/prp2.70259.

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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.

Rainard Fuhr, Dr. med. principal investigator

PAREXEL Early Phase Clinical Unit Berlin, On the premises of Klinikum Westend, Haus 31, Spandauer Damm 130, 14050 Berlin, Germany

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD4831 in people with Cardiovascular Disease, run by AstraZeneca.

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 31 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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. 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?

Frequencies of adverse events (time frame: From screening up to 10 days post final dose). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02712372, which also lists 1 linked publication.

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 6 Jan 2017.