A Phase 1 interventional study of AZD5718 oral suspension and Placebo matching AZD5817 oral suspension in Coronary Artery Disease, sponsored by AstraZeneca. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-15.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 25 studies in Coronary Artery Disease by AstraZeneca — 1 open to participants now, 1 under way, none of them phase 3. Coronary Artery Disease · AstraZeneca.
Among the 25 studies in Coronary Artery Disease by AstraZeneca, this one is the 15th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 in phase 1, and was the 20th registered.
4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.
Browse Coronary Artery Disease studies →1 of the 25 studies in Coronary Artery Disease by AstraZeneca is open now, in 4 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Denmark, France and 1 more country
Ages 12–130
By country, each count listing its studies:
Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.
This study: 18 Years to 50 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 76 across the 22 interventional studies, 10,568 across the 3 observational. Of the 24 that completed or were terminated, 11 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 25 studies in Coronary Artery Disease by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.
This study will be a Phase 1, randomized, single-blind, placebo-controlled, single and multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects, performed at a single study center. The planned number of cohorts is 4 but up to 6 cohorts may be included if the Safety Review Committee (SRC) considers it necessary to repeat a dose level or if additional dose steps are required. Screening will be completed between Days -28 and -1. Primarily gradual escalation of the dose will be conducted with the oral suspension. Eight subjects will participate in each cohort. Four ascending dose levels are planned. Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised to receive placebo. Each subject will receive one dose of AZD5718 or placebo on the first dosing day (Day 1, single ascending dose, SAD) and on Days 3 to 10 (multiple ascending dose, MAD). On Day 2 no dose will be given to the subject. In total each subject will receive 9 doses. Dosing for each ascending dose cohort will proceed after the SRC has evaluated the safety, tolerability and other relevant data of a completed cohort. The subjects will stay at the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a follow-up visit. Each subject will be involved in the study for 7 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy male Japanese subjects aged 18-50 years with suitable veins for cannulation or repeated venipuncture. A subject will be considered as Japanese if:
Exclusion Criteria:
Abnormal vital signs, after 10 minutes supine rest, at screening and check-in, defined as any of the following (repeat evaluations may be done once if the values for a subject are outside the designated range at screening and on Day -1):
Systolic blood pressure \< 90 mmHg or > 140 mmHg Diastolic blood pressure \< 50 mmHg or > 90 mmHg Heart rate \< 45 or > 90 beats per minute (bpm)
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized subjects will receive orally once daily dose of AZD5718 oral suspension on Day 1 (SAD) and MAD from Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.
Drug: AZD5718 oral suspension
Randomized subjects will receive orally once daily dose of placebo matching AZD5718 oral suspension on Day 1 (SAD) and MAD form Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.
Other: Placebo matching AZD5817 oral suspension
In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.
In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.
Number of patients with Adverse Events (AEs) due to AZD5817
To assess the adverse events as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. Adverse Events will be collected from the start of randomization throughout the treatment period up to and including the follow-up visit. Serious adverse events (SAEs) will be recorded from the time of informed consent.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Supine vital sign (Systolic Blood pressure [BP])
To assess the vital sign as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Supine vital sign (pulse rate)
To assess the vital sign as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Number of participants with abnormal findings in electrocardiograms (ECGs) (safety ECGs, digital ECGs [dECG])
To assess any clinically important abnormalities in the cardiovascular system functioning as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. A 12-lead 10-second safety ECG will be performed with the Schiller Cardiovit CS-200 recorder immediately following all scheduled dECGs. 12-lead continuous dECG will be recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder and transmitted to the AstraZeneca central dECG repository, according to AstraZeneca ECG Center´s standard procedures for settings, recording, and transmission of dECGs. For dECG, QTcF (QT interval corrected for heart rate using Fridericia's formula) will be calculated as QTcF =(QT\*(RR/1000)\^(-1/3)), where RR (the time between corresponding points on 2 consecutive R waves on ECG) is presented in milliseconds. Heart rate (HR) will also be calculated, based on the RR interval.
Time frame: From baseline up to follow-up (7 to 10 days post-(final) dose). For dECG: Days 1 to 12
Number of participants with abnormal cardiac telemetry
To assess any clinically important abnormalities in the cardiovascular system functioning (heart beat/rythm) using 2-lead real-time telemetry ECG as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The telemetry monitoring system will be reviewed by the Investigator or research nurse and paper printouts of any clinically important events will be stored as source data.
Time frame: From baseline up to Day 10
Number of participants with abnormal findings in physical examinations
To assess any clinically important abnormal findings in physical conditions as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The complete physical examinations include an 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. The brief physical examinations include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an adverse event.
Time frame: From baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (leukocyte count)
To assess the leukocyte count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Supine vital sign (diastolic BP)
To assess the vital sign as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (sodium)
To assess the clinical chemistry value (sodium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Urinalysis (glucose)
To assess urinalysis (glucose) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Red blood cell [RBC] count)
To assess the RBC count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Hemoglobin [Hb])
To assess the Hb as a criterion of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Hematocrit [HCT])
To assess the HCT as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Mean corpuscular volume [MCV])
To assess the MCV as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Mean corpuscular hemoglobin [MCH])
To assess the MCH as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Mean corpuscular hemoglobin concentration [MCHC])
To assess the MCHC as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (potassium)
To assess the clinical chemistry value (potassium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (urea)
To assess the clinical chemistry value (urea) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (creatinine)
To assess the clinical chemistry value (creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (albumin)
To assess the clinical chemistry value (albumin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (calcium)
To assess the clinical chemistry value (calcium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (phosphate)
To assess the clinical chemistry value (phosphate) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (glucose (fasting))
To assess the clinical chemistry value (glucose (fasting)) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (insulin)
To assess the clinical chemistry value (insulin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (fibrinogen)
To assess the clinical chemistry value (fibrinogen) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (thyroid-stimulating hormone)
To assess the clinical chemistry value (thyroid-stimulating hormone) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Urinalysis (blood)
To assess urinalysis (blood) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell \[WBC\], casts \[cellular, granular, hyaline\]).
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Urinalysis (protein)
To assess urinalysis (protein) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Urinalysis (urine creatinine)
To assess urinalysis (urine creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Differential Count)
To assess the differential count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Platelets)
To assess the platelets as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Hematology (Reticulocytes absolute count)
To assess the reticulocytes absolute count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (High sensitivity-C-reactive protein [CRP])
To assess the clinical chemistry value (CRP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Free T4)
To assess the clinical chemistry value (Free T4) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Alkaline phosphatase [ALP])
To assess the clinical chemistry value (ALP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Alanine aminotransferase [ALT])
To assess the clinical chemistry value (ALT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Aspartate aminotransferase [AST])
To assess the clinical chemistry value (AST) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Gamma glutamyl transpeptidase [GGT])
To assess the clinical chemistry value (GGT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Total Bilirubin)
To assess the clinical chemistry value (total bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Unconjugated bilirubin)
To assess the clinical chemistry value (unconjugated bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Glutamate dehydrogenase)
To assess the clinical chemistry value (glutamate dehydrogenase) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Laboratory assessment: Clinical chemistry (Lactate dehydrogenase [LDH])
To assess the clinical chemistry value (LDH) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.
Time frame: Change from baseline up to follow-up (7 to 10 days post-(final) dose)
Plasma PK assessment: Observed maximum plasma concentration (Cmax) assessment for AZD5817 after single and repeated oral dosing
To assess Cmax of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Time to reach peak or maximum observed concentration following drug administration (tmax) assessment for AZD5817 after single and repeated oral dosing
To assess tmax of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Terminal rate constant (λZ) assessment for AZD5817 after single and repeated oral dosing
To assess λZ of AZD5718 after single and repeated oral dosing. λZ will be estimated by log-linear least-squares regression of the terminal part of the concentration-time curve.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Terminal half-life (t½λz) assessment for AZD5817 after single and repeated oral dosing
To assess t½λz of AZD5718 after single and repeated oral dosing. t½λz will be estimated as (ln2)/λZ.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)) assessment for AZD5817 after single and repeated oral dosing
To assess AUC(0-24) of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0-last)) assessment for AZD5817 after single and repeated oral dosing
To assess AUC(0-last) of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) assessment for AZD5817 after single and repeated oral dosing
To assess AUC(0-τ) of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) assessment for AZD5817 after single and repeated oral dosing
To assess AUC of AZD5718 after single and repeated oral dosing. AUC is estimated by AUC(0-last) + Clast/λZ where Clast is the last observed quantifiable concentration.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) assessment for AZD5817 after single and repeated oral dosing
To assess CL/F of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Mean Residence Time (MRT) assessment for AZD5817 after single and repeated oral dosing
To assess MRT of AZD5718 after single and repeated oral dosing.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose
Plasma PK assessment: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), (Vz/F) assessment for AZD5817 after single and repeated oral dosing
To assess Vz/F of AZD5718 after single and repeated oral dosing. Vz/F will be estimated by dividing the apparent clearance (CL/F) by λZ.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Plasma PK assessment: Observed minimum concentration, (Cmin) assessment for AZD5817 after single and repeated oral dosing (Day 10)
To assess Cmin of AZD5718 after single and repeated oral dosing. Cmin will be taken directly from the individual concentration-time curve.
Time frame: Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose
Plasma PK assessment: Observed average concentration (Cavg) assessment for AZD5817 after single and repeated oral dosing (Day 10)
To assess Cavg of AZD5718 after single and repeated oral dosing. Cavg will be taken directly from the individual concentration-time curve.
Time frame: Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose
Plasma PK assessment: Accumulation ratio (Rac Cmax) assessment for AZD5817 after single and repeated oral dosing
To assess Rac Cmax of AZD5718 after single and repeated oral dosing. Rac Cmax will be calculated as Cmax Day 10/ Cmax Day 1.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose
Plasma PK assessment: Accumulation ratio (Rac AUC) assessment for AZD5817 after single and repeated oral dosing
To assess Rac AUC of AZD5718 after single and repeated oral dosing. Rac AUC will be calculated as AUCτ Day 10/ AUCτ Day 1.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose
Plasma PK assessment: Temporal change parameter in systemic exposure (TCP) assessment for AZD5817 after single and repeated oral dosing
To assess TCP of AZD5718 after single and repeated oral dosing. TCP will be calculated as AUCτDay 10/AUCDay 1.
Time frame: Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose
Urine PK assessment: Cumulative amount of unchanged drug excreted in urine from time zero to the last sampling interval (Ae(0-last)) assessment for AZD5817 after single and repeated oral dosing
To assess Ae(0-last) of AZD5718 after single and repeated oral dosing.
Time frame: Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine
Urine PK assessment: Fraction of dose excreted unchanged into the urine from time zero to the last sampling interval measured time point for an analyte (Fe(0-last)) assessment for AZD5817 after single and repeated oral dosing
To assess Fe(0-last) of AZD5718 after single and repeated oral dosing. Fe(0-last) will be estimated by dividing Ae(0-last) by dose.
Time frame: Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine
Urine PK assessment: Renal clearance of drug from plasma (CLR) assessment for AZD5817 after single and repeated oral dosing
To assess CLR of AZD5718 after single and repeated oral dosing. CLR will be estimated by dividing Ae(0-last) by AUC(0-t)).
Time frame: Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine
PD parameter: urine Leukotriene E4 (LTE4) assessment for AZD5817 after single and repeated oral dosing
To evaluate the PD of AZD5718, by assessment of urine LTE4 (u-LTE4), after single and repeated oral dosing.
Time frame: Day -1 (spot sample), Day 1 and Day 10 spot sample pre-dose and pooled 0-3, 3-6, 6-9 and 9-12 hours urine, spot sample at 24, 36 hours post-dose, Day 3-9: spot sample pre-dose
Ran from Jan 2018 to primary completion in Jun 2018, 4 months.
Of 34 phase 1 interventional studies under Coronary Artery Disease, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 4 months is below that.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AZD5718