A Phase 1 interventional study of AZD9977 Oral suspension (reference) and AZD9977 capsule 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 2018-06-15.
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 34th 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 20th 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 13 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 study will evaluate pharmacokinetics (PK) of four different formulations with different release profiles of AZD9977 (PART A) in the fasted state, and one of the formulation will be selected for further development (Part B). In Part B, the influence of food on the PK of AZD9977 will be evaluated
This study is a randomized, open-label, single-center study conducted on 12 healthy male subjects. This consists of three periods:
The study is divided into 2 parts: Part A and B. The subjects will participate in both Part A and Part B. Part A will be a 4-way cross-over study to compare the PK of 3 different solid formulations with different release rates with an oral suspension of AZD9977 in fasting conditions. Subjects in Part A will receive the following treatments on Days 1, 3, 5 and 7:
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:
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 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.
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.
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.
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.
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.
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.
In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 oral suspension (reference) AZD9977 capsule AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate)
Drug: AZD9977 Oral suspension (reference) · Drug: AZD9977 capsule · Drug: AZD9977 ER capsule (fastvrate) · Drug: AZD9977 ER capsule (Int. rate)
In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 capsule AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate) AZD9977 oral suspension (reference)
Drug: AZD9977 Oral suspension (reference) · Drug: AZD9977 capsule · Drug: AZD9977 ER capsule (fastvrate) · Drug: AZD9977 ER capsule (Int. rate)
In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate) AZD9977 Oral suspension (reference) AZD9977 capsule
Drug: AZD9977 Oral suspension (reference) · Drug: AZD9977 capsule · Drug: AZD9977 ER capsule (fastvrate) · Drug: AZD9977 ER capsule (Int. rate)
In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 ER capsule (Int. rate) AZD9977 Oral suspension (reference) AZD9977 capsule AZD9977 ER capsule (fast rate)
Drug: AZD9977 Oral suspension (reference) · Drug: AZD9977 capsule · Drug: AZD9977 ER capsule (fastvrate) · Drug: AZD9977 ER capsule (Int. rate)
Randomized subjects will receive single oral dose of AZD9977 oral suspension 15 mg/mL on Days 1, 3, 5 and 7 in Part A.
Randomized subjects will receive single oral dose of AZD9977 capsule 65 mg on Days 1, 3, 5 and 7 in Part A.
Randomized subjects will receive single oral dose of AZD9977 ER capsule (fast rate) 65 mg on Days 1, 3, 5 and 7 in Part A.
Randomized subjects will receive single oral dose of AZD9977 ER capsule (Int rate) 65 mg on Days 1, 3, 5 and 7 in Part A.
Relative bioavailability (Frel) of AZD9977 capsule, ER (fast rate) and ER (Int. rate) capsules versus AZD9977 oral suspension (reference): Area under plasma concentration-time curve from time zero to infinity (AUC)
To assess Frel by assessments of PK parameters AUC after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Relative bioavailability (Frel) of AZD9977 capsule, ER (fast rate) and ER (Int. rate) capsules versus AZD9977 oral suspension (reference): Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
To assess Frel by assessments of PK parameters AUClast after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Relative bioavailability (Frel) of AZD9977 capsule, ER (fast rate) and ER (Int. rate) capsules versus AZD9977 oral suspension (reference): Area under the plasma concentration-time curve from time zero to time 24 hours (AUC[0-24])
To assess Frel by assessments of PK parameters AUC\[0-24\] after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Relative bioavailability (Frel) of AZD9977 capsule, ER (fast rate) and ER (Int. rate) capsules versus AZD9977 oral suspension (reference): Maximum observed plasma concentration (Cmax )
To assess Frel by assessments of PK parameters Cmax after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Area under plasma concentration-time curve from time zero to infinity (AUC)
To assess AUC after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
To assess AUClast after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Maximum observed plasma concentration (Cmax)
To assess Cmax after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Area under the plasma concentration-time curve from time zero to time 24 hours (AUC[0-24])
To assess AUC(0-24) after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7
The Effect of food on the PK of one of the solid formultaion evaluated in Part A under fasting and fed conditions in Part B
To evaluate the influence of food by comparing AUC and Cmax under fasting and fed conditions for one of the solid formulations evaluated in Part A.
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Plasma concentration 24 hours post-dose (C4)
To assess C24 after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A and Part B - Day 1 (24 hours post-dose)
Plasma PK parameter: Time to reach maximum observed plasma concentration (tmax)
To assess tmax after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz )
To assess t½λz after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
To assess MRT after administration of single oral dose of AZD9977 capsule, ER (fast rate and Int. rate) capsules and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Terminal elimination rate constant (λz)
To assess λz after administration of single oral dose of AZD9977 capsule, ER (fast rate and Int. rate) capsules and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Apparent total body clearance of drug from plasma after extravascular administration AZD9977 (CL/F)
To assess CL/F after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Plasma PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration AZD9977 (Vz/F)
To assess Vz/F after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: Dosing sessions: Part A: Days 1, 3, 5 and 7; Part B: Day 1
Number of subjects with adverse events (AEs) due to AZD9977
To assess AEs as variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). 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 screening up to follow-up (5 to 7 days after final dose)
Vital sign: Blood pressure [BP]
To assess supine position systolic and diastolic BP as variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). Both SBP and DBP will be collected after the subject has rested in the supine position for at least 5 minutes.
Time frame: From screening up to follow-up (5 to 7 days after final dose)
Vital sign: Pulse rate
To assess supine position pulse rate as variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). Pulse rate will be collected after the subject has rested in the supine position for at least 5 minutes.
Time frame: From screening up to follow-up (5 to 7 days after final dose)
Number of participants with abnormal findings in Resting 12-lead Electrocardiogram (ECG)
To assess any clinically significant abnormalities in the cardiovascular system functioning using a 10-second 12-lead ECG as variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). The specific type and nature of the abnormality will be documented in ClinBase. Clinically significant findings will also be documented on the AE page of the CRF if applicable.
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final 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 single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). Brief physical examination includes assessment of the general appearance, skin, abdomen, cardiovascular system and respiratory. Full physical examination includes assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Blood cells count
To assess red blood cells ( RBC) and white blood cells (WBC) countas a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Hemoglobin (Hb)
To assess Hb as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Hematocrit (HCT) and Reticulocyte absolute count
To assess HCT (RBC) and reticulocyte absolute count (immature RBCs) as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Mean corpuscular volume (MCV)
To assess MCV as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Mean corpuscular hemoglobin (MCH)
To assess MCH as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Mean corpuscular hemoglobin concentration (MCHC)
To assess MCHC as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Differential count
To assess differential WBC count (absolute count of neutrophils, lymphocytes, monocyets, eosinophils and basophils) as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Hematology - Platelets
To assess platelets count as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - sodium, potassium, calcium and phosphate
To assess serum sodium, potassium, calcium and phosphate level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Urea and Uric acid
To assess serum urea and uric acid level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Creatinine
To assess serum creatinine level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Albumin
To assess serum albumin level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Glucose (fasting)
To assess serum fasting glucose level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - C-reactive protein (CRP)
To assess serum CRP level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Liver enzymes
To assess serum Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma glutamyl transpeptidase (GGT) level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Bilirubin
To assess serum bilirubin (total and unconjugated) level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - High-sensitivity troponin T
To assess serum high-sensitivity troponin T level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - Creatine kinase
To assess serum creatine kinase level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Serum Clinical chemistry - N-terminal-pro-brain natriuretic peptide (NT-proBNP)
To assess serum NT-proBNP level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Clinical Urinalysis - Glucose
To assess urine glucose level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Clinical Urinalysis - Protein
To assess urine protein level as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Laboratory assessments: Clinical Urinalysis - Blood
To assess presence of blood in urine as a variable of safety and tolerability after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference). If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
Time frame: At screening, dosing sessions of Part A and Part B and follow-up (5 to 7 days after final dose)
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Jun 2018, 2 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 2 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