Coronary Artery Disease (CAD)Phase 1NCT04210388
A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy Volunteers
A Phase 1 study testing AZD5718 tablet, Formulation A, AZD5718 tablet, Formulation B and AZD5718 tablet, Formulation C in people with Coronary Artery Disease (CAD), run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. In this study, the relative bioavailability of different formulations of AZD5718 will be assessed in healthy volunteers in order to compare the exposure of Formulations A to D to the AZD5718… 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 (CAD)
- What is being tested?
- AZD5718 tablet, Formulation A, AZD5718 tablet, Formulation B and AZD5718 tablet, Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2020to 9 Mar 2020
- 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
- For inclusion in the study volunteers should fulfill the following criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male or female volunteers aged 18 to 55 years (inclusive at screening) 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 screening and on admission to the Clinical Unit (Day -1), must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling the criteria.
- 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
- Volunteers will not enter the study if any of the following exclusion criteria are fulfilled:
- 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, 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 dosing.
- Any clinically significant abnormalities in hematology, clinical chemistry, or urinalysis results, at screening or on admission to the Clinical Unit (Day -1), as judged by the Investigator, including:
- Alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN).
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- Aspartate aminotransferase (AST) >1.5 x ULN.
- Total bilirubin (TBL) >1.5 x ULN.
- Gamma glutamyl transpeptidase (GGT) >1.5 x ULN. Out-of-range test may be repeated once for each visit at the discretion of the Investigator.
- Known or suspected Gilbert's syndrome.
- Any clinically significant abnormal findings in vital signs at screening or on admission to the Clinical Unit, as judged by the Investigator.
- Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the Investigator.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
- Known or suspected history of drug abuse, 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 first dosing 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.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- 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 screening.
- Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate) as judged by the Investigator.
- Positive screen for drugs of abuse or cotinine at screening or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to first dosing.
- 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 first dosing or longer if the medication has a long half-life.
- Known or suspected history of alcohol or excessive alcohol intake, as judged by the Investigator.
- Involvement of any AstraZeneca, Parexel or study site employee or their close relatives.
- Volunteers who have previously received AZD5718.
- Judgement by the Investigator that the volunteers 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.
- Vulnerable volunteers, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Healthy Volunteers
The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. In this study, the relative bioavailability of different formulations of AZD5718 will be assessed in healthy volunteers in order to compare the exposure of Formulations A to D to the AZD5718 film-coated tablet formulation. The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover.
Read the detailed description
This study will be conducted at a single study center in Parexel Early Phase Clinical Unit London.
A total of 12 healthy male and female volunteers (of non-childbearing potential) will be randomized.
The study will comprise:
- A screening period of maximum 28 days
- Five treatment periods
- There will be a washout period of 3 to 6 days between dose administrations
- Follow-up visit, 5 to 7 days after last dose
Each volunteer will be involved in the study for between 7 and 9 weeks. The volunteers will be admitted to the Unit on the day before first dosing in Treatment Period 1 until at least 72 hours after last dosing in Treatment Period 5.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- AZD5718 tablet, Formulation A, AZD5718 tablet, Formulation B, AZD5718 tablet, Formulation C, AZD5718 tablet, Formulation D, AZD5718 film-coated tablet, Reference treatment
- Keywords
- Relative Bioavailability, Crossover Study, Safety
- 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.
AZD5718 tablet, Formulation ADrug
Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation BDrug
Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation CDrug
Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 tablet, Formulation DDrug
Volunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
AZD5718 film-coated tablet, Reference treatmentDrug
Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| AZD5718 tablet, Treatment A | Experimental | Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. Receives: Drug: AZD5718 tablet, Formulation A |
| AZD5718 tablet, Treatment B | Experimental | Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. Receives: Drug: AZD5718 tablet, Formulation B |
| AZD5718 tablet, Treatment C | Experimental | Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. Receives: Drug: AZD5718 tablet, Formulation C |
| AZD5718 tablet, Treatment D | Experimental | Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. Receives: Drug: AZD5718 tablet, Formulation D |
| AZD5718 film-coated tablet | Active comparator | Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. Receives: Drug: AZD5718 film-coated tablet, Reference treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero to infinity (AUC)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Maximum observed plasma concentration (Cmax)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Drug concentration at 24 hours after dosing (C24)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Time to reach maximum observed plasma concentration (tmax)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Terminal elimination rate constant (λz)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Dose normalized AUC (AUC/D)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Dose normalized AUClast (AUClast/D)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Dose normalized Cmax (Cmax/D)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Dose normalized C24 (C24/D)
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
Secondary outcomes (1)
Number of volunteers with having adverse events and/or abnormal findings in vital signs and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or body weight
To further assess the safety and tolerability of single doses of AZD5718 in healthy volunteers
Measured: From Screening up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start14 Jan 2020
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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 overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover. The following treatments will be given: Treatment A: AZD5718 (Formulation A) Treatment B: AZD5718 (Formulation B) Treatment C: AZD5718 (Formulation C) Treatment D: AZD5718 (Formulation D) AZD5718 (AZD5718 film-coated tablet, Reference treatment)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Dr Pablo Forte Soto, Principal investigator, Senior Clinical Research Physician, Parexel Early Phase Clinical Unit London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210388
- Sponsor's protocol ID
- D7550C00008
- Status last verified
- Mar 2020
- First submitted
- 23 Dec 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04210388
- Acronym / sponsor ID
- D7550C00008
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Relative Bioavailability, Crossover Study, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 24 Dec 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.
The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. In this study, the relative bioavailability of different formulations of AZD5718 will be assessed in healthy volunteers in order to compare the exposure of Formulations A to D to the AZD5718 film-coated tablet formulation. The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover.
Detailed description
This study will be conducted at a single study center in Parexel Early Phase Clinical Unit London.
A total of 12 healthy male and female volunteers (of non-childbearing potential) will be randomized.
The study will comprise:
- A screening period of maximum 28 days
- Five treatment periods
- There will be a washout period of 3 to 6 days between dose administrations
- Follow-up visit, 5 to 7 days after last dose
Each volunteer will be involved in the study for between 7 and 9 weeks. The volunteers will be admitted to the Unit on the day before first dosing in Treatment Period 1 until at least 72 hours after last dosing in Treatment Period 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover. The following treatments will be given: Treatment A: AZD5718 (Formulation A) Treatment B: AZD5718 (Formulation B) Treatment C: AZD5718 (Formulation C) Treatment D: AZD5718 (Formulation D) AZD5718 (AZD5718 film-coated tablet, Reference treatment)
| Arm | Type | Receives |
|---|---|---|
| AZD5718 tablet, Treatment A | Experimental | Drug: AZD5718 tablet, Formulation AVolunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. |
| AZD5718 tablet, Treatment B | Experimental | Drug: AZD5718 tablet, Formulation BVolunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. |
| AZD5718 tablet, Treatment C | Experimental | Drug: AZD5718 tablet, Formulation CVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. |
| AZD5718 tablet, Treatment D | Experimental | Drug: AZD5718 tablet, Formulation DVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. |
| AZD5718 film-coated tablet | Active comparator | Drug: AZD5718 film-coated tablet, Reference treatmentVolunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male or female volunteers aged 18 to 55 years (inclusive at screening) 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 screening and on admission to the Clinical Unit (Day -1), must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling the criteria.
- 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.
Key exclusion criteria (27 listed)
- Volunteers will not enter the study if any of the following exclusion criteria are fulfilled:
- 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, 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 dosing.
- Any clinically significant abnormalities in hematology, clinical chemistry, or urinalysis results, at screening or on admission to the Clinical Unit (Day -1), as judged by the Investigator, including:
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 |
|---|---|---|
| AZD5718 tablet, Formulation AVolunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. | Drug | AZD5718 tablet, Treatment A |
| AZD5718 tablet, Formulation BVolunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. | Drug | AZD5718 tablet, Treatment B |
| AZD5718 tablet, Formulation CVolunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. | Drug | AZD5718 tablet, Treatment C |
| AZD5718 tablet, Formulation DVolunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. | Drug | AZD5718 tablet, Treatment D |
| AZD5718 film-coated tablet, Reference treatmentVolunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. | Drug | AZD5718 film-coated tablet |
Primary outcome
Area under the plasma concentration-time curve from zero to infinity (AUC)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Drug concentration at 24 hours after dosing (C24)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Time to reach maximum observed plasma concentration (tmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Terminal elimination rate constant (λz)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Dose normalized AUC (AUC/D)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Dose normalized AUClast (AUClast/D)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Dose normalized Cmax (Cmax/D)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
Dose normalized C24 (C24/D)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-dose
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
1 secondary outcome
Number of volunteers with having adverse events and/or abnormal findings in vital signs and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or body weight
Time frame: From Screening up to 9 weeks
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 25 Mar 2020.
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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.
Dr Pablo Forte Soto principal investigator
Senior Clinical Research Physician, Parexel Early Phase Clinical Unit London
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 AZD5718 tablet, Formulation A, AZD5718 tablet, Formulation B and AZD5718 tablet, Formulation C in people with Coronary Artery Disease (CAD), 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 6 inclusion and 27 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 25 Mar 2020. 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?
Area under the plasma concentration-time curve from zero to infinity (AUC) (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post-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?
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 25 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.