A Phase 1 interventional study of AZD9977 and Placebo in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-21.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 64 studies in Heart Failure by AstraZeneca — 6 open to participants now, 8 under way, 3 of them phase 3. Heart Failure · AstraZeneca.
Among the 64 studies in Heart Failure by AstraZeneca, this one is the 31st largest by enrollment of the 39 interventional ones that give a count, is one of 8 that started in 2018, is one of 13 in phase 1, and was the 19th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →6 of the 64 studies in Heart Failure by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, Australia and 29 more countries
Ages 18+
AstraZeneca · Sites in United States, Germany, Portugal and 2 more countries
Ages 18+
AstraZeneca · Sites in United States, Denmark, France and 1 more country
Ages 12–130
AstraZeneca · Sites in United States, Argentina, Australia and 32 more countries
Ages 40+
AstraZeneca · Sites in United States, Argentina, Australia and 36 more countries
Ages 18–130
By country, each count listing its studies:
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 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.
64 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 9 · Phase 3 16 · Phase 4 2
First in 1999; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 160 across the 39 interventional studies, 621 across the 25 observational. Of the 54 that completed or were terminated, 14 (26%) 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.
4 of the studies in Heart Failure by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06336330AstraZenecaReal-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany | 2026-12-31 |
| NCT07690436AstraZenecaRetinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM | 2027-06-18 |
| NCT06675552AstraZenecaNon-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 64 studies in Heart Failure by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized, single-blind, placebo-controlled study conducted on healthy male subjects at a single study center to assess the safety, tolerability and the pharmacokinetics of AZD9977 following multiple-ascending oral doses at steady state
This is a phase 1, randomized, single-blind, placebo-controlled, single center, multiple-ascending dose sequential-group design study conducted on 45 healthy male subjects to investigate the safety, tolerability, pharmacokinetics (PK) of AZD9977, time to reach steady state, the degree of accumulation and the time dependency of the PK. The study consists of three visits:
On Day 1 and Day 8, subjects will be fasted for 10 hours before dosing until 4 hours after dosing when lunch will be served. On Day 2 to Day 6, subjects will be fasted for 10 hours before dosing until 1 hour after dosing when breakfast will be served. On Day 7, subjects will be fasted for 10 hours before dosing and until after the completion of the oral glucose tolerance test (OGTT) when breakfast will be served. For the evening dose of IMP (Days 2 to Day 7), subjects will be fasted for 2 hours before dosing until 1 hour after dosing. On all days, subjects will be allowed to drink freely until 1 hour before dosing to prevent dehydration before each morning and evening dose and water consumption could be resumed 1 hour after dosing.
Dosing for each ascending dose cohort will proceed with 2 subjects in a sentinel cohort, such that 1 subject will be randomized to receive placebo and 1 subject will be randomized to receive AZD9977. The safety data from the sentinel subjects up to 72 hours post first dose will be reviewed by the principal investigator (PI) before the remaining subjects in the cohort are dosed. Following review of data from the study, the SRC may decide to adjust the length of the stay at the study site and the timing and number of assessments and/or blood samples for subsequent cohorts. The time window between the single dose and start of repeated dosing may also be adjusted. The duration of the study is approximately 6 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.
Exclusion Criteria:
Any clinically important abnormalities in rhythm, conduction or morphology of the resting and any clinically important abnormalities in the 12-lead ECG as judged by the Investigator that may interfere with the interpretation of changes, including abnormal ST-T-wave morphology, particularly in the CSP defined primary lead or LV hypertrophy at the Screening Visit or/and admission.
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 blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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 AZD9977 50 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose Day 2 to Day 7
Drug: AZD9977 · Other: Placebo
Randomized subjects will receive AZD9977 150 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7
Drug: AZD9977 · Other: Placebo
Randomized subjects will receive AZD9977 300 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7
Drug: AZD9977 · Other: Placebo
Randomized subjects will receive AZD9977 oral suspension at a dose of 50 mg in Cohort 1, 150 mg in Cohort 2 and 300 mg in Cohort 3
Randomized subjects will receive orally AZD9977 matched placebo in Cohorts 1, 2 and 3
Number of subjects with adverse events (AEs) due to AZD9977
To assess AEs as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. AEs will be collected from the start of screening throughout the treatment period up to and including the follow-up visit. Serious AEs will be recorded from the time of informed consent.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Systolic blood pressure [SBP]
To measure SBP as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. SBP will be collected after the subject has rested in the supine position for at least 10 minutes.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Diastolic blood pressure [DBP]
To measure DBP as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. DBP will be collected after the subject has rested in the supine position for at least 10 minutes.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Pulse rate
To measure pulse as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. Pulse rate will be collected after the subject has rested in the supine position for at least 10 minutes.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments of urine volume
To assess the urine volume as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Number of participants with abnormal findings in Twelve-lead (12-Lead) electrocardiograms (ECGs) (safety ECGs and 12-lead continuous digital ECG [dECG])
To assess any clinically significant abnormalities on cardiac electrophysiological parameters as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. 12-lead safety ECG and dECG will be obtained after the participant rested in the supine position for at least 10 minutes. Safety ECG will be collected at the end of each dECG recording. Various dECG variables like time between 2 consecutive R waves on ECG (RR), ECG interval measured form onset of P wave to the onset of QRS complex (PR), ECG interval measured from onset of QRS complex to the J point (QRS) and ECG interval measured form onset of QRS complex to the end of the T wave (QT intervals) will be reported. Derived parameters like QT interval corrected for heart rate using Fridericia's formula (QTcF), heart rate (HR) and others, as applicable are also calculated.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Number of participants with abnormal cardiac telemetry
To assess any clinically significant abnormalities in the cardiovascular system functioning as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. A 2-lead real-time telemetry ECG will be used to assess the heart rate.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Number of participants with abnormal physical examination findings
To assess any clinically significant abnormal physical examination findings as a variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. Brief physical examination includes assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen. Full physical examination includes 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.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Differential count
To assess the differential white blood cell count (absolute count of basophils, eosinophils, lymphocytes, monocyets and neutrophils) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Hematocrit (HCT) and Reticulocyte absolute count
To assess the HCT (red blood cells \[RBC\]) and reticulocyte absolute count (immature RBCs) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Hemoglobin (Hb)
To assess the Hb as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Mean corpuscular hemoglobin (MCH)
To assess the MCH as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Mean corpuscular hemoglobin concentration (MCHC)
To assess the MCHC as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Mean corpuscular volume (MCV)
To assess the MCV as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Platelets
To assess platelets count as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Hematology - Blood cells count
To assess RBC and white blood cells (WBC) count as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Albumin
To assess the serum albumin level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - C reactive protein (CRP)
To assess the serum CRP level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Creatine kinase (CK)
To assess the serum CK level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Creatinine
To assess the serum creatinine level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Glucose (fasting)
To assess the serum fasting glucose level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Calcium, potassium, phosphate and sodium
To assess the serum calcium, potassium, phosphate and sodium level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Urea and Uric acid
To assess the serum urea and uric acid level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Liver enzymes
To assess the serum Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Gamma glutamyl transpeptidase (GGT) level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Bilirubin
To assess the serum bilirubin (total and unconjugated) level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Steroid
To assess the serum cholesterol and triglycerides level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Luteinizing hormone (LH)
To assess the serum LF level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Sex hormone binding globulin (SHBG)
To assess the serum SHBG level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Testosterone
To assess the serum testosterone level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Aldosterone
To assess the serum aldosterone level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Hemoglobin A1c (HbA1c)
To assess the serum HbA1c level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - High-sensitivity troponin T
To assess the serum high-sensitivity troponin T level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - N-terminal pro-brain natriuretic peptide (NT-proBNP)
To assess the serum NT-proBNP level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Serum Clinical chemistry - Follicle-stimulating hormone (FSH)
To assess the serum FSH level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Clinical Urinalysis - Protein
To assess the urine protein level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Clinical Urinalysis - Blood
To assess the urine blood level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Clinical Urinalysis - Glucose
To assess the urine glucose level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Clinical Urinalysis - Uric acid
To assess the urine uric acid level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Clinical Urinalysis - Creatinine
To assess the urine creatinine level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Laboratory assessments: Urinalysis - Urinary Electrolytes
To assess the urine electrolytes level (calcium, chloride, potassium and sodium) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
Time frame: From baseline up to follow-up (5 to 7 days post last dose)
Plasma PK parameter: Observed maximum plasma concentration (Cmax)
To assess Cmax after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Time to reach maximum concentration (tmax)
To assess tmax after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Terminal half-life (t1/2λz)
To assess t1/2λz after administration of multiple dose of AZD9977 oral suspension; estimated as (ln2)/λz
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Terminal rate constant (λz)
To assess λz after administration of multiple dose of AZD9977 oral suspension; estimated by log-linear least squares regression of the terminal part of the concentration-time curve
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Area under the plasma concentration-time curve in the dosing interval (AUCτ)
To assess AUCτ after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast)
To assess AUClast after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period:Day 1and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Apparent volume of distribution for parent drug at terminal phase (Vz/F)
To assess Vz/F after administration of multiple dose of AZD9977 oral suspension, estimated by dividing the apparent
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Apparent clearance for parent drug (CL/F)
To assess CL/F after administration of multiple dose of AZD9977 oral suspension, estimated as dose divided by AUC
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Dose normalized AUCτ (AUCτ/D)
To assess AUCτ/D after administration of multiple dose of AZD9977 oral suspension, estimated by dividing AUCτ by the dose administered
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Dose normalized Cmax (Cmax/D)
To assess Cmax/D after administration of multiple dose of AZD9977 oral suspension, estimated by dividing Cmax by the dose administered
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Mean Residence Time (MRT)
To assess MRT after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period:Day 1 and Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
To assess AUC after administration of multiple dose of AZD9977 oral suspension. AUC is estimated by AUClast+ Clast/λz where Clast is the last observed quantifiable concentration
Time frame: Treatment period:Day 1 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Dose normalized AUC (AUC/D)
To assess AUC/D after administration of multiple dose of AZD9977 oral suspension. AUC is estimated by dividing AUC by the dose administered.
Time frame: Treatment period:Day 1 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Dose normalized AUClast (AUClast/D)
To assess AUClast/D after administration of multiple dose of AZD9977 oral suspension; estimated by dividing AUClast by the dose administered.
Time frame: Treatment period:Day 1 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Observed concentration at the end of the dosing interval (Cmin)
To assess Cmin after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period: Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Accumulation ratio for AUCτ (Rac AUCτ)
To assess Rac AUCτ after administration of multiple dose of AZD9977 oral suspension; estimated by dividing AUCτ from the last dosing day by AUCτ on Day 1
Time frame: Treatment period: Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Accumulation ratio for AUCτ (Rac Cmax)
To assess Rac Cmax after administration of multiple dose of AZD9977 oral suspension; estimated by dividing maximum (peak) steady-state plasma drug concentration (Css,max) from the last dosing day by Cmax on Day 1
Time frame: Treatment period: Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Plasma PK parameter: Temporal change (TCP)
To assess TCP after administration of multiple dose of AZD9977 oral suspension; estimated by dividing AUCτ from the last dosing day by AUC on Day 1
Time frame: Treatment period: Day 8 (Pre-dose & 20 min, 40 min, 1, 2, 4, 6, 8, 10, 12, 16, & 20 hours post-dose)
Urine PK parameter: Renal clearance (CLR)
To assess CLR after administration of multiple dose of AZD9977 oral suspension; estimated by dividing amount of analyte excreted into urine (Ae\[0-t\]) by AUC(0-t) where the time interval for both parameters are the same
Time frame: Treatment period: Day 8 (Pre-dose and 0-4, 4-8 and 8-12 hours post-dose)
Urine PK parameter: Amount of analyte excreted into the urine from time t1 to t2 (Ae[t1-t2])
To assess Ae(t1-t2) after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period: Day 8 (Pre-dose and 0-4, 4-8 and 8-12 hours post-dose)
Urine PK parameter: Percentage Fraction of dose excreted in urine from time t1 to t2 (fe[t1-t2]%)
To assess fe(t1-t2)% after administration of multiple dose of AZD9977 oral suspension.
Time frame: Treatment period: Day 8 (Pre-dose and 0-4, 4-8 and 8-12 hours post-dose)
Plan to share: No
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Ran from Feb 2018 to primary completion in Jun 2018, 3 months.
Of 77 industry-sponsored phase 1 interventional studies under Heart Failure, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 16. This study's 3 months is below that.
Counting every sponsor, half of 131 studies reached it within 14 months; a quarter within 4 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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: AZD9977