Coronary Artery DiseasePhase 1NCT04087187

A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Coronary Artery Disease, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to determine exposure in a new dose range and compare with previous results. This study will include 14 subjects in a single site in United Kingdom. Each subject will be involved in the study for 6 to 7 weeks. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease
What is being tested?: Treatment A, Treatment B and Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: 20 Sep 2019to 31 Oct 2019
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/or female subjects aged 18 to 55 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
Males must be willing to use appropriate contraception methods.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Day -1) must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria
Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range.
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer'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.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator including:
Alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN).
Aspartate aminotransferase (AST) >1.5 x ULN.

Show all 26Show fewer

Bilirubin (total) >1.5 x ULN.
Gamma glutamyl transpeptidase (GGT) >1.5 x ULN.
Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator.
Any clinically significant abnormalities on 12 lead ECG at the Screening Visit, as judged by the Investigator.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Known or suspected history of drug abuse, as judged by the Investigator.
Known or suspected Gilbert's syndrome.
Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the 3 administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous Phase I study, are not excluded.
Plasma donation within 1 month of the Screening Visit 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, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.
Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate,) as judged by the Investigator.
Positive screen for drugs of abuse, alcohol or cotinine at the Screening Visit or on admission to the Clinical Unit.
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 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 prior to the first administration of IMP or longer if the medication has a long half-life.
Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
Subjects who have previously received AZD5718.
Judgment by the Investigator that the subject 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.
Vulnerable subjects, eg, 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.

United Kingdom1 site

Research Site
London, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Randomized, 3-period, 3-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Pharmacokinetics of 3 Doses of AZD5718

Read the detailed description

This study will be an open-label, randomized, 3-period, 3-treatment, crossover study performed in healthy subjects at a single study center.

A total of 14 healthy male and female subjects (of no childbearing potential) will be randomized to ensure that at least 12 subjects are evaluable. Each subject will receive 3 different treatments at least 4 days apart and will be dosed following an overnight fast of at least 10 hours. The following treatments will be given:

Treatment A: AZD5718 Dose A tablet
Treatment B: AZD5718 Dose B tablet
Treatment C: AZD5718 Dose C tablet

The study will comprise:

A Screening Period of maximum 28 days.
Three Treatment Periods during which subjects will be resident from the day before first dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples. Subjects will be discharged on Day 3 of Treatment Period 3.
A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product (IMP).

There will be a minimum washout period of 4 days between each dose administration.

Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in male and female subjects aged 18 to 55 years.

Conditions: Coronary Artery Disease
Being tested: Treatment A, Treatment B, Treatment C
Keywords: Pharmacokinetics
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment ADrug
Subject will be given AZD5718 Dose A tablet once daily
Treatment BDrug
Subjects will be given AZD5718 Dose B tablet once daily
Treatment CDrug
Subjects will be given AZD5718 Dose C tablet once daily

Study groups in NCT04087187
Study group	Role	What they receive
Arm1: AZD5718 Dose A + AZD5718 Dose B + AZD5718 Dose C	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment A: AZD5718 Dose A, Treatment B: AZD5718 Dose B, Treatment C: AZD5718 Dose C, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Arm2: AZD5718 Dose A + AZD5718 Dose C + AZD5718 Dose B	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment A: AZD5718 Dose A, Treatment C: AZD5718 Dose C, Treatment B: AZD5718 Dose B, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Arm3: AZD5718 Dose B + AZD5718 Dose A + AZD5718 Dose C	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment B: AZD5718 Dose B, Treatment A: AZD5718 Dose A, Treatment C: AZD5718 Dose C, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Arm4: AZD5718 Dose B + AZD5718 Dose C + AZD5718 Dose A	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment B: AZD5718 Dose B, Treatment C: AZD5718 Dose C, Treatment A: AZD5718 Dose A, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Arm5: AZD5718 Dose C + AZD5718 Dose A + AZD5718 Dose B	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment C: AZD5718 Dose C, Treatment A: AZD5718 Dose A, Treatment B: AZD5718 Dose B, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Arm6: AZD5718 Dose C + AZD5718 Dose B + AZD5718 Dose A	Experimental	Subjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment C: AZD5718 Dose C, Treatment B: AZD5718 Dose B, Treatment A: AZD5718 Dose A, with a minimum washout period of 4 days between each dose administration. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

What is being measured

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

Pharmacokinetic parameter: Area under plasma concentration time curve from zero to infinity (AUC)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Area under the plasma concentration curve from time zero to time of last quantifiable concentration (AUClast)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Drug concentration 24 hours after dosing (C24)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Time to reach maximum observed plasma concentration (tmax)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose

Secondary outcomes (3)

Number of subjects with advers event
Number of subjects with adverse event and/or abnormal vital signs or physical examination or laboratory assessments to further assess the safety of single doses of AZD5718 in healthy subjects.
Measured: Upto 7 weeks
Pharmacokinetic parameter: AUC
To assess dose proportionality of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Cmax
To assess dose proportionality of AZD5718
Measured: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 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.

20 Sep 201931 Oct 2019

First posted12 Sep 2019
Study start20 Sep 2019
Primary completion31 Oct 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The following treatments will be given in crossover design: * Treatment A: AZD5718 Dose A tablet * Treatment B: AZD5718 Dose B tablet * Treatment C: AZD5718 Dose C tablet There will be 6 arms consisting of all possible treatment sequences. The treatment sequence per arm will be: Arm1: ABC Arm2: ACB Arm3: BAC Arm4: BCA Arm5: CAB Arm6: CBA
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04087187
Sponsor's protocol ID: D7550C00009
Status last verified: Nov 2019
First submitted: 19 Aug 2019
Last updated: 15 Nov 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 3-period, 3-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Pharmacokinetics of 3 Doses of AZD5718
ClinicalTrials.gov ID: NCT04087187
Acronym / sponsor ID: D7550C00009
Conditions: Coronary Artery Disease
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 20 Sep 2019 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 12 Sep 2019 (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.

Detailed description

This study will be an open-label, randomized, 3-period, 3-treatment, crossover study performed in healthy subjects at a single study center.

Treatment A: AZD5718 Dose A tablet
Treatment B: AZD5718 Dose B tablet
Treatment C: AZD5718 Dose C tablet

The study will comprise:

A Screening Period of maximum 28 days.
Three Treatment Periods during which subjects will be resident from the day before first dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples. Subjects will be discharged on Day 3 of Treatment Period 3.
A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product (IMP).

There will be a minimum washout period of 4 days between each dose administration.

Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in male and female subjects aged 18 to 55 years.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: The following treatments will be given in crossover design: * Treatment A: AZD5718 Dose A tablet * Treatment B: AZD5718 Dose B tablet * Treatment C: AZD5718 Dose C tablet There will be 6 arms consisting of all possible treatment sequences. The treatment sequence per arm will be: Arm1: ABC Arm2: ACB Arm3: BAC Arm4: BCA Arm5: CAB Arm6: CBA

Arm	Type	Receives
Arm1: AZD5718 Dose A + AZD5718 Dose B + AZD5718 Dose C	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment A: AZD5718 Dose A, Treatment B: AZD5718 Dose B, Treatment C: AZD5718 Dose C, with a minimum washout period of 4 days between each dose administration.
Arm2: AZD5718 Dose A + AZD5718 Dose C + AZD5718 Dose B	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment A: AZD5718 Dose A, Treatment C: AZD5718 Dose C, Treatment B: AZD5718 Dose B, with a minimum washout period of 4 days between each dose administration.
Arm3: AZD5718 Dose B + AZD5718 Dose A + AZD5718 Dose C	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment B: AZD5718 Dose B, Treatment A: AZD5718 Dose A, Treatment C: AZD5718 Dose C, with a minimum washout period of 4 days between each dose administration.
Arm4: AZD5718 Dose B + AZD5718 Dose C + AZD5718 Dose A	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment B: AZD5718 Dose B, Treatment C: AZD5718 Dose C, Treatment A: AZD5718 Dose A, with a minimum washout period of 4 days between each dose administration.
Arm5: AZD5718 Dose C + AZD5718 Dose A + AZD5718 Dose B	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment C: AZD5718 Dose C, Treatment A: AZD5718 Dose A, Treatment B: AZD5718 Dose B, with a minimum washout period of 4 days between each dose administration.
Arm6: AZD5718 Dose C + AZD5718 Dose B + AZD5718 Dose A	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CSubjects will receive one tablet once daily (QD) of each treatment according to treatment arm. Treatment C: AZD5718 Dose C, Treatment B: AZD5718 Dose B, Treatment A: AZD5718 Dose A, with a minimum washout period of 4 days between each dose administration.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and/or female subjects aged 18 to 55 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
Males must be willing to use appropriate contraception methods.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Day -1) must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria

Key exclusion criteria (26 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer'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.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator including:
Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator.

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
Treatment ASubject will be given AZD5718 Dose A tablet once daily	Drug	Arm1: AZD5718 Dose A + AZD5718 Dose B + AZD5718 Dose C, Arm2: AZD5718 Dose A + AZD5718 Dose C + AZD5718 Dose B, Arm3: AZD5718 Dose B + AZD5718 Dose A + AZD5718 Dose C, Arm4: AZD5718 Dose B + AZD5718 Dose C + AZD5718 Dose A, Arm5: AZD5718 Dose C + AZD5718 Dose A + AZD5718 Dose B, Arm6: AZD5718 Dose C + AZD5718 Dose B + AZD5718 Dose A
Treatment BSubjects will be given AZD5718 Dose B tablet once daily	Drug	Arm1: AZD5718 Dose A + AZD5718 Dose B + AZD5718 Dose C, Arm2: AZD5718 Dose A + AZD5718 Dose C + AZD5718 Dose B, Arm3: AZD5718 Dose B + AZD5718 Dose A + AZD5718 Dose C, Arm4: AZD5718 Dose B + AZD5718 Dose C + AZD5718 Dose A, Arm5: AZD5718 Dose C + AZD5718 Dose A + AZD5718 Dose B, Arm6: AZD5718 Dose C + AZD5718 Dose B + AZD5718 Dose A
Treatment CSubjects will be given AZD5718 Dose C tablet once daily	Drug	Arm1: AZD5718 Dose A + AZD5718 Dose B + AZD5718 Dose C, Arm2: AZD5718 Dose A + AZD5718 Dose C + AZD5718 Dose B, Arm3: AZD5718 Dose B + AZD5718 Dose A + AZD5718 Dose C, Arm4: AZD5718 Dose B + AZD5718 Dose C + AZD5718 Dose A, Arm5: AZD5718 Dose C + AZD5718 Dose A + AZD5718 Dose B, Arm6: AZD5718 Dose C + AZD5718 Dose B + AZD5718 Dose A

Primary outcome

Pharmacokinetic parameter: Area under plasma concentration time curve from zero to infinity (AUC)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Area under the plasma concentration curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Drug concentration 24 hours after dosing (C24)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Time to reach maximum observed plasma concentration (tmax)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718
Pharmacokinetic parameter: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718

3 secondary outcomes

Number of subjects with advers event
Time frame: Upto 7 weeks
Pharmacokinetic parameter: AUC
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose
Pharmacokinetic parameter: Cmax
Time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose

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 15 Nov 2019.

Related trials for Coronary Artery Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

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 Treatment A, Treatment B and Treatment C in people with Coronary Artery Disease, 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 7 inclusion and 26 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 15 Nov 2019. 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?

Pharmacokinetic parameter: Area under plasma concentration time curve from zero to infinity (AUC) (time frame: Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose). The study lists 7 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 NCT04087187.

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 15 Nov 2019.