Smoking Cessation
Conditions
Keywords
Safety, Tolerability, Pharmacokinetics, Healthy Volunteers
Brief summary
This is a Phase I, first-in-human (FIH), single-center, randomized, double-blind, placebo controlled, single ascending dose, sequential group study in healthy vasectomized male and female subjects of non-childbearing potential, aged 18 to 65 years.
Interventions
DRUGAZD4041
Administration by Oral syringe
DRUGPlacebo
Administration by Oral syringe
Sponsors
National Institutes of Health (NIH)
Eolas Therapeutics INC.
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this clinical study protocol. 2. Provision of signed and dated, written Informed Consent Form prior to any mandatory study specific procedures, sampling, and analyses. 3. Subjects must be ≥18 and less than or equal to 65 years of age at the time of signing the Informed Consent Form. 4. Individuals who are healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. 5. Individuals who weigh ≥50 kg and who have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. 6. Either male or female. 7. Female subjects must have a negative pregnancy test result at screening and check-in and, on admission to the unit, must not be lactating. 8. Female subjects must be of non-childbearing potential, as confirmed at screening by fulfilling one of the following criteria: 1. Post-menopausal women must have had ≥12 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) concentration consistently ≥40 mIU/mL and must have a negative pregnancy test result at screening and check-in. 2. Surgically sterile women, defined as those who have had a hysterectomy, bilateral ovariectomy (oophorectomy), bilateral salpingectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report or relevant medical records, or by ultrasound, and must have a negative pregnancy test result at screening and check-in. 9. Male subjects must be vasectomized.
Exclusion criteria
1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. 2. History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (American Psychiatric Association 2013) which, in the opinion of the Investigator, could be detrimental to subject safety or could compromise study data interpretation. 3. Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system. 4. Subjects who are undergoing treatment or evaluation for infertility. 5. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. 6. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of administration of Investigational Product. 7. Any clinically important abnormalities noted at the screening assessments in clinical chemistry, hematology, or urinalysis results as judged by the Investigator. 8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus antibodies. 9. Abnormal vital signs, after 10 minutes supine rest, defined as any of the following: 1. Systolic BP \<90 mmHg or ≥140 mmHg. 2. Diastolic BP \<50 mmHg or ≥90 mmHg. 3. HR \<45 or \>85 beats per minute. 10. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG which, in the Investigator's opinion, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology. 11. ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) \>450 ms or family history of long QT syndrome. 12. ECG interval measured from the onset of the P wave to the onset of the QRS complex (PR\[PQ\]) interval shortening \<120 ms (PR \>110 ms but \<120 ms is acceptable if there is no evidence of ventricular pre-excitation). 13. PR(PQ) interval prolongation (\>240 ms), persistent or intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation. 14. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with ECG interval measured from the onset of the QRS complex to the J point (QRS) \>110 ms. Subjects with QRS \>110 ms but \<115 ms are acceptable if there is no evidence of, eg, ventricular hypertrophy or pre-excitation. 15. Known or suspected history of drug abuse as judged by the Investigator. 16. Current smokers or those who have smoked or used nicotine products within the previous 3 months. 17. History of alcohol abuse or excessive intake of alcohol defined as an average weekly intake of \>21 units or an average daily intake of \>3 units for men or an average weekly intake of \>14 units or an average daily intake of \>2 units for women. One unit is equivalent to a half pint (250 mL) of beer, 1 measure (25 mL) of spirits, or 1 glass (125 mL) of wine. If a subject is currently diagnosed with abuse of or dependence on alcohol, the subject will not be allowed to enroll in the study, unless the alcohol abuse/dependence is in full (complete, not partial), sustained (\>1 year) remission. 18. Positive screen for drugs of abuse at screening or admission to the unit or positive screen for alcohol at screening to the unit prior to administration of IP. 19. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4041. 20. Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening. 21. Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the Investigator. 22. Use of drugs with enzyme inducing properties, such as St John's wort, within 3 weeks prior to administration of IP. 23. Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to administration of IP or longer if the medication has a long half life. 24. Use of any prescribed or nonprescribed oral and topical inhibitors/inducers of CYP3A4 (including shampoo). 25. Use of hormone replacement therapy. 26. Subjects who have previously received AZD4041. 27. Has received another new chemical entity (defined as a compound that has not been approved for marketing) within 3 months of administration of IP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit, whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous Phase I study, are not excluded. 28. Involvement of any AstraZeneca or study site employee or their close relatives. 29. Judgement by the Investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements. 30. Subjects who are vegans or have medical dietary restrictions. 31. Subjects who cannot communicate reliably with the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Inhibin B Test Results | Thru Day 4 | Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Aggregate QRS Complex at Baseline and Times Post Dose | Thru Day 4 | QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs) |
| Aggregate QT Interval at Baseline and Times Post Dose | Thru Day 4 | The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs) |
| Aggregate QTcF Interval and Times Post Dose | Thru Day 4 | The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs) |
| Aggregate RR Interval at Baseline and Times Post Dose | Thru Day 4 | The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs) |
| Number of Participants With Abnormal Testosterone Test Results | Thru Day 4 | Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal Luteinizing Hormone Test Results | Thru Day 4 | Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | Thru Day 4 | Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Treatment-Related SAEs | 6 weeks | Number of participants experiencing any treatment-related serious adverse events (SAEs) |
| Number of Participants With TEAEs Leading to Early Discontinuation | 6 weeks | Number of participants with treatment-emergent adverse events leading to early discontinuation |
| Number of Participant Deaths | 6 weeks | Number of participants who died |
| Number of Adverse Events | 6 weeks | Number of participants experiencing any adverse event |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 weeks | Number of participants experiencing any treatment emergent adverse events |
| Number of Participants With Treatment-Related TEAEs | 6 weeks | Number of participants experiencing any treatment-related TEAEs |
| Number of Participants With Moderate TEAEs | 6 weeks | Number of participants experiencing any moderate TEAEs |
| Number of Participants With Treatment-Related Moderate TEAEs | 6 weeks | Number of participants experiencing any treatment-related moderate TEAEs |
| Number of Participants With Severe TEAEs | 6 weeks | Number of participants experiencing any severe TEAEs |
| Number of Participants With Treatment-Related Severe TEAEs | 6 weeks | Number of participants experiencing any treatment-related severe TEAEs |
| Number of Participants With Serious Adverse Events (SAEs) | 6 weeks | Number of participants experiencing any serious adverse events (SAEs) |
| Number of Participants With Abnormal Vital Signs | 6 weeks | Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator. |
| Number of Participants With Abnormal Vital Signs (Blood Pressure) | 6 weeks | Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal Vital Signs (Heart Rate) | 6 weeks | Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline and Day 1 | Measured by standing pulse rate at baseline and 2 hours post |
| Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 6 weeks | Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 6 weeks | Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 6 weeks | Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Number of Participants With Abnormal 12-lead ECGs | 4 days | Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator |
| Heart Rate at Baseline and Times Post Dose | Thru Day 4 | Measured by digital electrocardiograms (ECGs) |
| Aggregate P-R Interval at Baseline and Time Post Dose | Thru Day 4 | PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CL/F (Volume/Time) | Thru Day 4 | Apparent total clearance of the AZD4041 from plasma |
| Cmax of AZD4041 | Thru Day 4 | Maximum (peak) plasma concentration of AZD4041 |
| Tmax of AZD4041 | Thru Day 4 | Time to reach maximum (peak) plasma concentration of AZD4041 |
| AUC0-t | Thru Day 4 | Area under the curve of AZD4041 from time 0 to time t (AUC from zero to the last measurable concentration) |
| AUC0-inf | Thru Day 4 | Extrapolation of the area under the curve of AZD4041 from zero to infinity |
| Vss/F (Plasma) | Thru Day 4 | Apparent volume of distribution of AZD4041 at steady state |
| t1/2λz | Thru Day 4 | Terminal half-life of AZD4041 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Single dose oral solution pooled from 6 cohorts | 12 |
| AZD4041 X mg Single dose oral solution | 6 |
| AZD4041 3X mg Single dose oral solution | 6 |
| AZD4041 9X mg Single dose oral solution | 6 |
| AZD4041 20X mg Single dose oral solution | 6 |
| AZD4041 40X mg Single dose oral solution | 6 |
| AZD4041 80X mg Single dose oral solution | 6 |
| Total | 48 |
Baseline characteristics
| Characteristic | Total | AZD4041 80X mg | AZD4041 40X mg | AZD4041 20X mg | AZD4041 X mg | AZD4041 9X mg | Pooled Placebo | AZD4041 3X mg |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.7 Years STANDARD_DEVIATION 50.5 | 53.5 Years STANDARD_DEVIATION 11.67 | 46.2 Years STANDARD_DEVIATION 8.68 | 55.5 Years STANDARD_DEVIATION 4.85 | 49.8 Years STANDARD_DEVIATION 11.81 | 46.0 Years STANDARD_DEVIATION 14.99 | 46.6 Years STANDARD_DEVIATION 12.26 | 37.3 Years STANDARD_DEVIATION 14.49 |
| Body Mass Index (BMI) | 25.69 kg/m^2 STANDARD_DEVIATION 2.82 | 24.00 kg/m^2 STANDARD_DEVIATION 2.03 | 25.85 kg/m^2 STANDARD_DEVIATION 2.5 | 24.68 kg/m^2 STANDARD_DEVIATION 3.84 | 27.02 kg/m^2 STANDARD_DEVIATION 1.87 | 27.07 kg/m^2 STANDARD_DEVIATION 2.72 | 26.14 kg/m^2 STANDARD_DEVIATION 3.11 | 24.63 kg/m^2 STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.15 cm STANDARD_DEVIATION 9.78 | 159.02 cm STANDARD_DEVIATION 9.42 | 174.40 cm STANDARD_DEVIATION 6.53 | 164.88 cm STANDARD_DEVIATION 9.16 | 166.13 cm STANDARD_DEVIATION 12.51 | 165.17 cm STANDARD_DEVIATION 9.55 | 169.96 cm STANDARD_DEVIATION 9.37 | 167.70 cm STANDARD_DEVIATION 8.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 5 Participants | 5 Participants | 3 Participants | 5 Participants | 5 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 25 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 2 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 23 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants | 7 Participants | 5 Participants |
| Weight | 72.15 kg STANDARD_DEVIATION 12.34 | 61.03 kg STANDARD_DEVIATION 10.28 | 78.58 kg STANDARD_DEVIATION 8.63 | 67.62 kg STANDARD_DEVIATION 15.47 | 75.23 kg STANDARD_DEVIATION 13.923 | 74.37 kg STANDARD_DEVIATION 14.05 | 75.45 kg STANDARD_DEVIATION 10.62 | 69.47 kg STANDARD_DEVIATION 9.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 5 / 12 | 0 / 6 | 1 / 6 | 1 / 6 | 1 / 6 | 3 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Aggregate P-R Interval at Baseline and Time Post Dose
PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 152.1 milliseconds | Standard Deviation 8.16 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 153.7 milliseconds | Standard Deviation 9.78 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 151.6 milliseconds | Standard Deviation 8.02 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 151.9 milliseconds | Standard Deviation 6.14 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 150.7 milliseconds | Standard Deviation 7.98 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 151.9 milliseconds | Standard Deviation 7.66 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 150.8 milliseconds | Standard Deviation 9.3 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 148.7 milliseconds | Standard Deviation 5.52 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 150.8 milliseconds | Standard Deviation 10.5 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 150.1 milliseconds | Standard Deviation 6.97 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 150.4 milliseconds | Standard Deviation 8.75 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 152.3 milliseconds | Standard Deviation 9.18 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 150.9 milliseconds | Standard Deviation 7.54 |
| Pooled Placebo | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 151.8 milliseconds | Standard Deviation 8.67 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 151.0 milliseconds | Standard Deviation 8.97 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 149.7 milliseconds | Standard Deviation 6.44 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 151.2 milliseconds | Standard Deviation 9 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 151.5 milliseconds | Standard Deviation 6.35 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 145.5 milliseconds | Standard Deviation 8.83 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 148.5 milliseconds | Standard Deviation 7.53 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 146.5 milliseconds | Standard Deviation 7.97 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 151.2 milliseconds | Standard Deviation 9.56 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 151.5 milliseconds | Standard Deviation 9.16 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 150.5 milliseconds | Standard Deviation 7.06 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 151.3 milliseconds | Standard Deviation 7.42 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 152.8 milliseconds | Standard Deviation 9.35 |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 151.5 milliseconds | Standard Deviation 8.67 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 170.8 milliseconds | Standard Deviation 12.75 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 166.5 milliseconds | Standard Deviation 15.4 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 163.5 milliseconds | Standard Deviation 12.01 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 169.2 milliseconds | Standard Deviation 12.77 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 170.3 milliseconds | Standard Deviation 12.37 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 169.2 milliseconds | Standard Deviation 12.27 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 163.7 milliseconds | Standard Deviation 9.37 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 166.2 milliseconds | Standard Deviation 10.93 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 165.0 milliseconds | Standard Deviation 10.49 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 170.8 milliseconds | Standard Deviation 14.47 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 170.3 milliseconds | Standard Deviation 12.44 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 160.7 milliseconds | Standard Deviation 7.23 |
| AZD4041 3X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 162.8 milliseconds | Standard Deviation 8.93 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 157.5 milliseconds | Standard Deviation 24.83 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 152.7 milliseconds | Standard Deviation 19.75 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 157.2 milliseconds | Standard Deviation 19.91 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 154.0 milliseconds | Standard Deviation 18.9 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 156.3 milliseconds | Standard Deviation 19.5 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 161.7 milliseconds | Standard Deviation 20.1 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 158.5 milliseconds | Standard Deviation 22.06 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 156.0 milliseconds | Standard Deviation 19.27 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 159.5 milliseconds | Standard Deviation 21.06 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 158.5 milliseconds | Standard Deviation 20.63 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 157.0 milliseconds | Standard Deviation 21.82 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 158.8 milliseconds | Standard Deviation 21.66 |
| AZD4041 9X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 155.0 milliseconds | Standard Deviation 20.01 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 151.7 milliseconds | Standard Deviation 16.97 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 150.8 milliseconds | Standard Deviation 15.99 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 152.0 milliseconds | Standard Deviation 17.18 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 146.8 milliseconds | Standard Deviation 13.64 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 150.3 milliseconds | Standard Deviation 15.56 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 153.5 milliseconds | Standard Deviation 19.73 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 151.3 milliseconds | Standard Deviation 17.96 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 151.3 milliseconds | Standard Deviation 18.78 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 147.8 milliseconds | Standard Deviation 12.77 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 144.2 milliseconds | Standard Deviation 12.77 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 156.3 milliseconds | Standard Deviation 19.67 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 151.2 milliseconds | Standard Deviation 17.02 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 151.0 milliseconds | Standard Deviation 16.76 |
| AZD4041 20X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 152.3 milliseconds | Standard Deviation 17.28 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 160.2 milliseconds | Standard Deviation 12.88 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 153.8 milliseconds | Standard Deviation 7.81 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 156.0 milliseconds | Standard Deviation 11.03 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 159.7 milliseconds | Standard Deviation 12.91 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 159.2 milliseconds | Standard Deviation 11.3 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 160.5 milliseconds | Standard Deviation 12.18 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 156.3 milliseconds | Standard Deviation 14.71 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 159.8 milliseconds | Standard Deviation 10.46 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 155.0 milliseconds | Standard Deviation 9.12 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 155.7 milliseconds | Standard Deviation 9.75 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 155.8 milliseconds | Standard Deviation 10.23 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 156.0 milliseconds | Standard Deviation 8.1 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 156.3 milliseconds | Standard Deviation 11.54 |
| AZD4041 40X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 155.3 milliseconds | Standard Deviation 11.38 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (36 hours) | 158.3 milliseconds | Standard Deviation 26.52 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (6 hours) | 154.7 milliseconds | Standard Deviation 20.27 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (4 hours) | 159.0 milliseconds | Standard Deviation 28.47 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (3 hours) | 158.7 milliseconds | Standard Deviation 28.68 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (2 hours) | 156.8 milliseconds | Standard Deviation 25.87 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 160.2 milliseconds | Standard Deviation 25.23 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 3 (48 hours) | 161.0 milliseconds | Standard Deviation 28.62 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1.5 hours) | 158.5 milliseconds | Standard Deviation 25.27 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (1 hour) | 158.7 milliseconds | Standard Deviation 25.63 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (0.5 hour) | 156.3 milliseconds | Standard Deviation 26.88 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Baseline | 154.5 milliseconds | Standard Deviation 27.05 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (12 hours) | 155.8 milliseconds | Standard Deviation 25.35 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 1 (8 hours) | 153.3 milliseconds | Standard Deviation 23.76 |
| AZD4041 80X mg | Aggregate P-R Interval at Baseline and Time Post Dose | Day 2 (24 hours) | 155.5 milliseconds | Standard Deviation 14.21 |
Primary
Aggregate QRS Complex at Baseline and Times Post Dose
QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 90.3 milliseconds | Standard Deviation 9 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 88.6 milliseconds | Standard Deviation 8.99 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 90.7 milliseconds | Standard Deviation 9.25 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 91.0 milliseconds | Standard Deviation 9.8 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 91.7 milliseconds | Standard Deviation 9.4 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 35.7 milliseconds | Standard Deviation 6.38 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 90.2 milliseconds | Standard Deviation 10.08 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 91.1 milliseconds | Standard Deviation 8.67 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 90.3 milliseconds | Standard Deviation 8.97 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 90.8 milliseconds | Standard Deviation 9.3 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 91.3 milliseconds | Standard Deviation 9.18 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 90.5 milliseconds | Standard Deviation 9.66 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 91.1 milliseconds | Standard Deviation 9.54 |
| Pooled Placebo | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 90.4 milliseconds | Standard Deviation 8.53 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 88.0 milliseconds | Standard Deviation 8.46 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 88.7 milliseconds | Standard Deviation 9.2 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 89.3 milliseconds | Standard Deviation 8.07 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 89.7 milliseconds | Standard Deviation 8.31 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 89.3 milliseconds | Standard Deviation 8.94 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 89.8 milliseconds | Standard Deviation 8.98 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 90.9 milliseconds | Standard Deviation 8.41 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 90.3 milliseconds | Standard Deviation 8.82 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 89.5 milliseconds | Standard Deviation 9.33 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 88.7 milliseconds | Standard Deviation 7.34 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 89.7 milliseconds | Standard Deviation 8.73 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 89.7 milliseconds | Standard Deviation 8.96 |
| AZD4041 X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 89.8 milliseconds | Standard Deviation 8.66 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 93.2 milliseconds | Standard Deviation 8.42 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 92.0 milliseconds | Standard Deviation 9.72 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 94.5 milliseconds | Standard Deviation 8.34 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 92.2 milliseconds | Standard Deviation 10.78 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 93.5 milliseconds | Standard Deviation 8.09 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 93.7 milliseconds | Standard Deviation 9.73 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 95.3 milliseconds | Standard Deviation 8.82 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 94.3 milliseconds | Standard Deviation 8.52 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 92.0 milliseconds | Standard Deviation 10.18 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 94.0 milliseconds | Standard Deviation 8.6 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 91.5 milliseconds | Standard Deviation 8.98 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 94.0 milliseconds | Standard Deviation 8.37 |
| AZD4041 3X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 93.8 milliseconds | Standard Deviation 8.89 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 89.8 milliseconds | Standard Deviation 8.73 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 90.5 milliseconds | Standard Deviation 10.01 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 90.2 milliseconds | Standard Deviation 7.57 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 89.8 milliseconds | Standard Deviation 8.11 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 91.3 milliseconds | Standard Deviation 9.44 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 90.7 milliseconds | Standard Deviation 8.66 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 89.5 milliseconds | Standard Deviation 8.62 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 90.3 milliseconds | Standard Deviation 7.79 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 91.0 milliseconds | Standard Deviation 9.08 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 89.3 milliseconds | Standard Deviation 9.85 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 89.8 milliseconds | Standard Deviation 9.83 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 91.3 milliseconds | Standard Deviation 9.18 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 90.2 milliseconds | Standard Deviation 8.38 |
| AZD4041 9X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 86.7 milliseconds | Standard Deviation 7.03 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 87.5 milliseconds | Standard Deviation 7.37 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 87.3 milliseconds | Standard Deviation 7.79 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 88.0 milliseconds | Standard Deviation 7.46 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 85.7 milliseconds | Standard Deviation 6.56 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 87.7 milliseconds | Standard Deviation 6.02 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 88.5 milliseconds | Standard Deviation 6.09 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 88.3 milliseconds | Standard Deviation 6.62 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 88.5 milliseconds | Standard Deviation 6.02 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 86.8 milliseconds | Standard Deviation 7.17 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 87.7 milliseconds | Standard Deviation 6.28 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 87.2 milliseconds | Standard Deviation 8.26 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 84.8 milliseconds | Standard Deviation 7.47 |
| AZD4041 20X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 87.2 milliseconds | Standard Deviation 8.13 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 86.8 milliseconds | Standard Deviation 8.52 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 87.7 milliseconds | Standard Deviation 11.62 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 88.0 milliseconds | Standard Deviation 9.67 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 89.2 milliseconds | Standard Deviation 9.93 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 87.8 milliseconds | Standard Deviation 10.42 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 87.5 milliseconds | Standard Deviation 8.92 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 87.8 milliseconds | Standard Deviation 9.5 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 88.0 milliseconds | Standard Deviation 10.49 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 37.7 milliseconds | Standard Deviation 7.74 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 87.7 milliseconds | Standard Deviation 8.5 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 88.0 milliseconds | Standard Deviation 11.3 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 86.0 milliseconds | Standard Deviation 7.87 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 88.3 milliseconds | Standard Deviation 11.25 |
| AZD4041 40X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 88.5 milliseconds | Standard Deviation 10.41 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 89.8 milliseconds | Standard Deviation 7.6 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Baseline | 88.0 milliseconds | Standard Deviation 9.53 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (6 hours) | 85.0 milliseconds | Standard Deviation 10.04 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (4 hours) | 89.2 milliseconds | Standard Deviation 7.83 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1.5 hours) | 88.5 milliseconds | Standard Deviation 8.76 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (2 hours) | 88.7 milliseconds | Standard Deviation 8.5 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 3 (48 hours) | 89.7 milliseconds | Standard Deviation 8.5 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (24 hours) | 86.5 milliseconds | Standard Deviation 9.54 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (0.5 hour) | 88.5 milliseconds | Standard Deviation 9.27 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (8 hours) | 87.7 milliseconds | Standard Deviation 8.52 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (1 hour) | 87.7 milliseconds | Standard Deviation 9.24 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (12 hours) | 89.8 milliseconds | Standard Deviation 8.93 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 1 (3 hours) | 89.5 milliseconds | Standard Deviation 8.92 |
| AZD4041 80X mg | Aggregate QRS Complex at Baseline and Times Post Dose | Day 2 (36 hours) | 80.0 milliseconds | Standard Deviation 8.12 |
Primary
Aggregate QTcF Interval and Times Post Dose
The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 384.3 milliseconds | Standard Deviation 21.21 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 383.0 milliseconds | Standard Deviation 27.25 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 382.8 milliseconds | Standard Deviation 20.7 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 383.0 milliseconds | Standard Deviation 20.91 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 381.0 milliseconds | Standard Deviation 38.33 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 388.0 milliseconds | Standard Deviation 24.8 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 383.9 milliseconds | Standard Deviation 20.34 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 384.5 milliseconds | Standard Deviation 23.77 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 382.2 milliseconds | Standard Deviation 21.46 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 386.6 milliseconds | Standard Deviation 25.9 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 387.0 milliseconds | Standard Deviation 38.04 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Baseline | 382.9 milliseconds | Standard Deviation 23.45 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 385.6 milliseconds | Standard Deviation 26.61 |
| Pooled Placebo | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 385.9 milliseconds | Standard Deviation 26.62 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 379.3 milliseconds | Standard Deviation 21.29 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 394.2 milliseconds | Standard Deviation 23.27 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 385.3 milliseconds | Standard Deviation 20.61 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 383.3 milliseconds | Standard Deviation 20.29 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 379.5 milliseconds | Standard Deviation 17.21 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 382.7 milliseconds | Standard Deviation 18.5 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 392.8 milliseconds | Standard Deviation 23.78 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 383.3 milliseconds | Standard Deviation 17.85 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 381.7 milliseconds | Standard Deviation 20.07 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 393.7 milliseconds | Standard Deviation 23.39 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 389.8 milliseconds | Standard Deviation 22.93 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 380.0 milliseconds | Standard Deviation 17.52 |
| AZD4041 X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 384.2 milliseconds | Standard Deviation 14.47 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 369.8 milliseconds | Standard Deviation 22.2 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 374.8 milliseconds | Standard Deviation 23.63 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 373.0 milliseconds | Standard Deviation 23.44 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 374.0 milliseconds | Standard Deviation 25.2 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 373.2 milliseconds | Standard Deviation 23.02 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 369.7 milliseconds | Standard Deviation 23.24 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 369.7 milliseconds | Standard Deviation 17.74 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 269.3 milliseconds | Standard Deviation 18.54 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 366.0 milliseconds | Standard Deviation 14.38 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 374.0 milliseconds | Standard Deviation 26.27 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 372.7 milliseconds | Standard Deviation 23.57 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 370.0 milliseconds | Standard Deviation 21.96 |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 367.3 milliseconds | Standard Deviation 20.22 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 371.8 milliseconds | Standard Deviation 15.25 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 375.2 milliseconds | Standard Deviation 18.32 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 373.8 milliseconds | Standard Deviation 16.39 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 374.7 milliseconds | Standard Deviation 16.39 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 372.8 milliseconds | Standard Deviation 15.41 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 371.0 milliseconds | Standard Deviation 17.85 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 375.0 milliseconds | Standard Deviation 19.31 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 375.7 milliseconds | Standard Deviation 18.48 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 376.3 milliseconds | Standard Deviation 18.45 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 379.5 milliseconds | Standard Deviation 17.21 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 376.2 milliseconds | Standard Deviation 12.83 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 373.8 milliseconds | Standard Deviation 18.37 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 378.3 milliseconds | Standard Deviation 14.32 |
| AZD4041 9X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 382.3 milliseconds | Standard Deviation 19.76 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 373.2 milliseconds | Standard Deviation 20.37 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 380.5 milliseconds | Standard Deviation 20.32 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 378.7 milliseconds | Standard Deviation 20.78 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 373.7 milliseconds | Standard Deviation 16.23 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 374.2 milliseconds | Standard Deviation 16.77 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 373.3 milliseconds | Standard Deviation 19.73 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 369.0 milliseconds | Standard Deviation 17.73 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 374.7 milliseconds | Standard Deviation 21.39 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 381.5 milliseconds | Standard Deviation 21.78 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 380.0 milliseconds | Standard Deviation 21.35 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 379.0 milliseconds | Standard Deviation 18.87 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 379.8 milliseconds | Standard Deviation 17.62 |
| AZD4041 20X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 380.0 milliseconds | Standard Deviation 20.31 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 411.8 milliseconds | Standard Deviation 16.8 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 396.7 milliseconds | Standard Deviation 13.47 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 398.5 milliseconds | Standard Deviation 19.93 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 411.7 milliseconds | Standard Deviation 18.08 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 400.5 milliseconds | Standard Deviation 9.59 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 409.3 milliseconds | Standard Deviation 20.03 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 405.3 milliseconds | Standard Deviation 18.95 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 400.8 milliseconds | Standard Deviation 19.16 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 398.7 milliseconds | Standard Deviation 14.5 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 403.8 milliseconds | Standard Deviation 20.09 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 406.3 milliseconds | Standard Deviation 22.34 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 402.0 milliseconds | Standard Deviation 17.34 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 402.7 milliseconds | Standard Deviation 17.39 |
| AZD4041 40X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 409.7 milliseconds | Standard Deviation 16.78 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (2 hours) | 409.7 milliseconds | Standard Deviation 22.05 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (36 hours) | 399.2 milliseconds | Standard Deviation 9.72 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Baseline | 404.7 milliseconds | Standard Deviation 18.98 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (3 hours) | 407.2 milliseconds | Standard Deviation 19.65 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1.5 hours) | 405.8 milliseconds | Standard Deviation 19.46 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (4 hours) | 407.8 milliseconds | Standard Deviation 21.86 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 3 (48 hours) | 404.3 milliseconds | Standard Deviation 13.65 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (8 hours) | 393.7 milliseconds | Standard Deviation 16.23 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 2 (24 hours) | 402.3 milliseconds | Standard Deviation 20.56 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (1 hour) | 403.3 milliseconds | Standard Deviation 22.06 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (6 hours) | 388.8 milliseconds | Standard Deviation 13.82 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (12 hours) | 399.0 milliseconds | Standard Deviation 17.05 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 1 (0.5 hour) | 398.0 milliseconds | Standard Deviation 17.79 |
| AZD4041 80X mg | Aggregate QTcF Interval and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 406.0 milliseconds | Standard Deviation 17.6 |
Primary
Aggregate QT Interval at Baseline and Times Post Dose
The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 377.8 milliseconds | Standard Deviation 23.95 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 389.9 milliseconds | Standard Deviation 31.5 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 369.3 milliseconds | Standard Deviation 24.74 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 380.4 milliseconds | Standard Deviation 22.44 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 382.5 milliseconds | Standard Deviation 29.29 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 390.0 milliseconds | Standard Deviation 30.11 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 379.5 milliseconds | Standard Deviation 40.02 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 375.2 milliseconds | Standard Deviation 28.5 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 384.5 milliseconds | Standard Deviation 31.22 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 377.9 milliseconds | Standard Deviation 26.52 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 377.7 milliseconds | Standard Deviation 27.94 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 390.6 milliseconds | Standard Deviation 30.4 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 391.8 milliseconds | Standard Deviation 28.72 |
| Pooled Placebo | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 391.8 milliseconds | Standard Deviation 30.12 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 363.0 milliseconds | Standard Deviation 12.43 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 384.8 milliseconds | Standard Deviation 17.95 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 356.5 milliseconds | Standard Deviation 21.5 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 374.8 milliseconds | Standard Deviation 18.88 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 377.8 milliseconds | Standard Deviation 21.61 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 266.0 milliseconds | Standard Deviation 19.05 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 380.8 milliseconds | Standard Deviation 19.08 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 373.2 milliseconds | Standard Deviation 13.42 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 388.7 milliseconds | Standard Deviation 19.94 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 370.2 milliseconds | Standard Deviation 20.31 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 383.5 milliseconds | Standard Deviation 20.52 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 371.7 milliseconds | Standard Deviation 13.85 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 382.0 milliseconds | Standard Deviation 21.14 |
| AZD4041 X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 381.5 milliseconds | Standard Deviation 24.83 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 274.8 milliseconds | Standard Deviation 21.45 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 380.3 milliseconds | Standard Deviation 18.36 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 383.8 milliseconds | Standard Deviation 25.19 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 367.8 milliseconds | Standard Deviation 29.36 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 381.2 milliseconds | Standard Deviation 21.98 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 379.8 milliseconds | Standard Deviation 22.42 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 363.8 milliseconds | Standard Deviation 15.88 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 364.2 milliseconds | Standard Deviation 17.93 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 382.5 milliseconds | Standard Deviation 24.7 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 389.5 milliseconds | Standard Deviation 27.27 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 374.3 milliseconds | Standard Deviation 24.06 |
| AZD4041 3X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 371.0 milliseconds | Standard Deviation 26.6 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 359.0 milliseconds | Standard Deviation 15.74 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 359.2 milliseconds | Standard Deviation 13.5 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 357.0 milliseconds | Standard Deviation 13.89 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 362.5 milliseconds | Standard Deviation 16.63 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 364.2 milliseconds | Standard Deviation 15.77 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 362.3 milliseconds | Standard Deviation 17.6 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 363.2 milliseconds | Standard Deviation 13.32 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 346.0 milliseconds | Standard Deviation 13.25 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 349.0 milliseconds | Standard Deviation 14.6 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 350.3 milliseconds | Standard Deviation 10.41 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 367.7 milliseconds | Standard Deviation 16.17 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 358.5 milliseconds | Standard Deviation 13.28 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 357.8 milliseconds | Standard Deviation 16.2 |
| AZD4041 9X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 363.0 milliseconds | Standard Deviation 11.76 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 345.0 milliseconds | Standard Deviation 21.95 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 374.5 milliseconds | Standard Deviation 12.77 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 357.0 milliseconds | Standard Deviation 21.25 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 358.0 milliseconds | Standard Deviation 19.71 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 374.3 milliseconds | Standard Deviation 21.4 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 357.8 milliseconds | Standard Deviation 21.15 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 373.2 milliseconds | Standard Deviation 16.09 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 359.7 milliseconds | Standard Deviation 20.2 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 377.2 milliseconds | Standard Deviation 14.55 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 366.3 milliseconds | Standard Deviation 17.66 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 356.5 milliseconds | Standard Deviation 23.67 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 376.7 milliseconds | Standard Deviation 16.6 |
| AZD4041 20X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 366.3 milliseconds | Standard Deviation 17.81 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 392.2 milliseconds | Standard Deviation 23.99 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 405.8 milliseconds | Standard Deviation 12.5 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 389.2 milliseconds | Standard Deviation 10.21 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 391.0 milliseconds | Standard Deviation 15.94 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 411.0 milliseconds | Standard Deviation 9.36 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 389.7 milliseconds | Standard Deviation 13.22 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 406.5 milliseconds | Standard Deviation 15.9 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 396.2 milliseconds | Standard Deviation 20.59 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 404.3 milliseconds | Standard Deviation 7.23 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 390.8 milliseconds | Standard Deviation 20.13 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 396.3 milliseconds | Standard Deviation 7.26 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 391.7 milliseconds | Standard Deviation 16.77 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 408.3 milliseconds | Standard Deviation 11.86 |
| AZD4041 40X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 386.2 milliseconds | Standard Deviation 13.23 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 405.3 milliseconds | Standard Deviation 30.58 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Baseline | 402.2 milliseconds | Standard Deviation 29.91 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 413.8 milliseconds | Standard Deviation 34.6 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 413.0 milliseconds | Standard Deviation 31.93 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 399.8 milliseconds | Standard Deviation 34.52 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 391.8 milliseconds | Standard Deviation 36.66 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 402.7 milliseconds | Standard Deviation 36.53 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 415.8 milliseconds | Standard Deviation 32.68 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 387.0 milliseconds | Standard Deviation 29.05 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 410.5 milliseconds | Standard Deviation 30.07 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 400.8 milliseconds | Standard Deviation 27.33 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 404.7 milliseconds | Standard Deviation 30.59 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 417.0 milliseconds | Standard Deviation 31.28 |
| AZD4041 80X mg | Aggregate QT Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 399.2 milliseconds | Standard Deviation 30.42 |
Primary
Aggregate RR Interval at Baseline and Times Post Dose
The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 950.9 milliseconds | Standard Deviation 102.54 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 960.9 milliseconds | Standard Deviation 81.9 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 1023.9 milliseconds | Standard Deviation 81.9 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 1030.5 milliseconds | Standard Deviation 101.07 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 1043.1 milliseconds | Standard Deviation 81.48 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 900.5 milliseconds | Standard Deviation 80.31 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 1035.2 milliseconds | Standard Deviation 95.4 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 973.3 milliseconds | Standard Deviation 142.46 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 931.5 milliseconds | Standard Deviation 102.06 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 1029.6 milliseconds | Standard Deviation 78.39 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 955.1 milliseconds | Standard Deviation 100.17 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 1041.4 milliseconds | Standard Deviation 100.88 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 998.9 milliseconds | Standard Deviation 94.86 |
| Pooled Placebo | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 990.7 milliseconds | Standard Deviation 112.51 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 875.8 milliseconds | Standard Deviation 67.69 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 938.3 milliseconds | Standard Deviation 102.44 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 832.7 milliseconds | Standard Deviation 83.65 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 942.0 milliseconds | Standard Deviation 62.03 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 900.3 milliseconds | Standard Deviation 101.7 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 968.3 milliseconds | Standard Deviation 89.63 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 957.5 milliseconds | Standard Deviation 55.03 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 930.3 milliseconds | Standard Deviation 130.67 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 915.3 milliseconds | Standard Deviation 90.73 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 958.0 milliseconds | Standard Deviation 107.71 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 965.5 milliseconds | Standard Deviation 84.72 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 909.2 milliseconds | Standard Deviation 85.41 |
| AZD4041 X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 925.2 milliseconds | Standard Deviation 94.41 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 1075.8 milliseconds | Standard Deviation 105.83 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 1089.3 milliseconds | Standard Deviation 148.54 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 959.5 milliseconds | Standard Deviation 74.07 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 1044.5 milliseconds | Standard Deviation 57.48 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 899.0 milliseconds | Standard Deviation 129.62 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 1012.3 milliseconds | Standard Deviation 101.19 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 1086.3 milliseconds | Standard Deviation 105.03 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 1068.2 milliseconds | Standard Deviation 78.58 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 1074.2 milliseconds | Standard Deviation 95.98 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 1126.0 milliseconds | Standard Deviation 123.29 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 985.0 milliseconds | Standard Deviation 78.92 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 1064.0 milliseconds | Standard Deviation 139.41 |
| AZD4041 3X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 1066.3 milliseconds | Standard Deviation 96.37 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 891.3 milliseconds | Standard Deviation 103.62 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 896.5 milliseconds | Standard Deviation 76.66 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 898.7 milliseconds | Standard Deviation 124.48 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 912.0 milliseconds | Standard Deviation 132.25 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 922.3 milliseconds | Standard Deviation 134.42 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 904.7 milliseconds | Standard Deviation 121.65 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 905.0 milliseconds | Standard Deviation 101.31 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 916.2 milliseconds | Standard Deviation 112.82 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 790.0 milliseconds | Standard Deviation 63.33 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 837.0 milliseconds | Standard Deviation 147.36 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 813.8 milliseconds | Standard Deviation 144.25 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 856.7 milliseconds | Standard Deviation 111.45 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 881.5 milliseconds | Standard Deviation 95.33 |
| AZD4041 9X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA milliseconds | — |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 983.3 milliseconds | Standard Deviation 99.76 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 962.0 milliseconds | Standard Deviation 74.11 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 894.8 milliseconds | Standard Deviation 92.5 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 960.7 milliseconds | Standard Deviation 89.4 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 884.7 milliseconds | Standard Deviation 94.73 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 941.8 milliseconds | Standard Deviation 71.97 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 906.8 milliseconds | Standard Deviation 88.49 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 966.5 milliseconds | Standard Deviation 85.55 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 927.0 milliseconds | Standard Deviation 90.52 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 819.2 milliseconds | Standard Deviation 86.55 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 836.0 milliseconds | Standard Deviation 110.22 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 826.3 milliseconds | Standard Deviation 76.49 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 939.0 milliseconds | Standard Deviation 70.03 |
| AZD4041 20X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 879.0 milliseconds | Standard Deviation 106.47 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 955.0 milliseconds | Standard Deviation 139.11 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 965.2 milliseconds | Standard Deviation 123.68 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 1003.5 milliseconds | Standard Deviation 141.24 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 929.8 milliseconds | Standard Deviation 147.8 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 989.7 milliseconds | Standard Deviation 144.62 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 973.8 milliseconds | Standard Deviation 139.99 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 1003.5 milliseconds | Standard Deviation 139.04 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 897.8 milliseconds | Standard Deviation 125.72 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 988.2 milliseconds | Standard Deviation 111.95 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 918.3 milliseconds | Standard Deviation 94.5 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 928.2 milliseconds | Standard Deviation 134.76 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 998.7 milliseconds | Standard Deviation 145.89 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 913.0 milliseconds | Standard Deviation 85.26 |
| AZD4041 40X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 929.7 milliseconds | Standard Deviation 128.82 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (0.5 hour) | 1059.8 milliseconds | Standard Deviation 153.49 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (4 hours) | 1063.7 milliseconds | Standard Deviation 145.71 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (2 hours) | 1059.3 milliseconds | Standard Deviation 152.01 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (3 hours) | 1048.8 milliseconds | Standard Deviation 158.48 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (8 hours) | 990.5 milliseconds | Standard Deviation 178.05 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (6 hours) | 996.2 milliseconds | Standard Deviation 184.44 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (24 hours) | 994.7 milliseconds | Standard Deviation 141.06 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1 hour) | 1057.8 milliseconds | Standard Deviation 138.05 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 3 (48 hours) | 996.0 milliseconds | Standard Deviation 196.5 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (1.5 hours) | 1071.5 milliseconds | Standard Deviation 207 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 1 (12 hours) | 1012.3 milliseconds | Standard Deviation 172.32 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 991.7 milliseconds | Standard Deviation 118.28 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Baseline | 985.0 milliseconds | Standard Deviation 127.74 |
| AZD4041 80X mg | Aggregate RR Interval at Baseline and Times Post Dose | Day 2 (36 hours) | 1004.0 milliseconds | Standard Deviation 170.62 |
Primary
Heart Rate at Baseline and Times Post Dose
Measured by digital electrocardiograms (ECGs)
Time frame: Thru Day 4
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 57.8 Beats per minute | Standard Deviation 4.8 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 63.5 Beats per minute | Standard Deviation 6.8 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 61.8 Beats per minute | Standard Deviation 6.9 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 58.0 Beats per minute | Standard Deviation 5.6 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 62.8 Beats per minute | Standard Deviation 9.9 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 63.8 Beats per minute | Standard Deviation 6.8 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 62.8 Beats per minute | Standard Deviation 5.64 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 59.0 Beats per minute | Standard Deviation 5 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 67.1 Beats per minute | Standard Deviation 6.02 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 65.0 Beats per minute | Standard Deviation 7.2 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 58.3 Beats per minute | Standard Deviation 5.8 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 58.6 Beats per minute | Standard Deviation 4.7 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Baseline | 60.7 Beats per minute | Standard Deviation 6.5 |
| Pooled Placebo | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 68.7 Beats per minute | Standard Deviation 5.9 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 66.2 Beats per minute | Standard Deviation 6.2 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 63.2 Beats per minute | Standard Deviation 6.8 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 62.5 Beats per minute | Standard Deviation 5.8 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA Beats per minute | — |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 72.7 Beats per minute | Standard Deviation 7.26 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 64.7 Beats per minute | Standard Deviation 7.2 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 66.5 Beats per minute | Standard Deviation 6.3 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 63.0 Beats per minute | Standard Deviation 4 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 65.5 Beats per minute | Standard Deviation 6.8 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 67.3 Beats per minute | Standard Deviation 7.87 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 62.5 Beats per minute | Standard Deviation 5.6 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 65.5 Beats per minute | Standard Deviation 8.3 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 64.0 Beats per minute | Standard Deviation 4.3 |
| AZD4041 X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 68.7 Beats per minute | Standard Deviation 5.2 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 57.2 Beats per minute | Standard Deviation 7.2 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 56.5 Beats per minute | Standard Deviation 4.1 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 63.0 Beats per minute | Standard Deviation 6.23 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 55.8 Beats per minute | Standard Deviation 5 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 53.7 Beats per minute | Standard Deviation 5.4 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 57.7 Beats per minute | Standard Deviation 3.2 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 56.2 Beats per minute | Standard Deviation 5 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 61.2 Beats per minute | Standard Deviation 4.6 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 56.0 Beats per minute | Standard Deviation 4.2 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA Beats per minute | — |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 55.8 Beats per minute | Standard Deviation 7.4 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 61.7 Beats per minute | Standard Deviation 8.3 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 56.7 Beats per minute | Standard Deviation 5.16 |
| AZD4041 3X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 59.7 Beats per minute | Standard Deviation 6.2 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 68.0 Beats per minute | Standard Deviation 8.3 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 67.3 Beats per minute | Standard Deviation 5.7 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 67.8 Beats per minute | Standard Deviation 8.9 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 67.0 Beats per minute | Standard Deviation 8.7 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 66.0 Beats per minute | Standard Deviation 9 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 67.2 Beats per minute | Standard Deviation 8.8 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 67.0 Beats per minute | Standard Deviation 7.4 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 66.2 Beats per minute | Standard Deviation 7.9 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 76.3 Beats per minute | Standard Deviation 6.06 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 73.5 Beats per minute | Standard Deviation 12.1 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 74.8 Beats per minute | Standard Deviation 9.9 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 71.0 Beats per minute | Standard Deviation 9.6 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 68.8 Beats per minute | Standard Deviation 7.22 |
| AZD4041 9X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | NA Beats per minute | — |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 61.7 Beats per minute | Standard Deviation 5.9 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 62.7 Beats per minute | Standard Deviation 5.2 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 67.7 Beats per minute | Standard Deviation 7.2 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 62.8 Beats per minute | Standard Deviation 5.9 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 68.3 Beats per minute | Standard Deviation 7.1 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 64.0 Beats per minute | Standard Deviation 5.1 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 66.7 Beats per minute | Standard Deviation 6.89 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 62.3 Beats per minute | Standard Deviation 5.1 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 65.3 Beats per minute | Standard Deviation 6.7 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 73.8 Beats per minute | Standard Deviation 7.91 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 73.0 Beats per minute | Standard Deviation 10.1 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 73.2 Beats per minute | Standard Deviation 6.6 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 64.2 Beats per minute | Standard Deviation 4.9 |
| AZD4041 20X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 69.0 Beats per minute | Standard Deviation 9.21 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 64.0 Beats per minute | Standard Deviation 9 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 63.2 Beats per minute | Standard Deviation 7 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 61.0 Beats per minute | Standard Deviation 8.3 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 65.7 Beats per minute | Standard Deviation 10.2 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 61.7 Beats per minute | Standard Deviation 8.4 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 62.5 Beats per minute | Standard Deviation 8.5 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 60.8 Beats per minute | Standard Deviation 8 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 67.8 Beats per minute | Standard Deviation 8.9 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 61.2 Beats per minute | Standard Deviation 6.4 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 66.0 Beats per minute | Standard Deviation 6.66 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 65.7 Beats per minute | Standard Deviation 8.8 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 61.0 Beats per minute | Standard Deviation 8.1 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 66.0 Beats per minute | Standard Deviation 6.3 |
| AZD4041 40X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 65.7 Beats per minute | Standard Deviation 8.45 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (0.5 hour) | 57.7 Beats per minute | Standard Deviation 8.24 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (4 hours) | 57.3 Beats per minute | Standard Deviation 7.8 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (2 hours) | 57.8 Beats per minute | Standard Deviation 8.3 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (3 hours) | 58.3 Beats per minute | Standard Deviation 9 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (8 hours) | 62.3 Beats per minute | Standard Deviation 11.2 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (6 hours) | 62.0 Beats per minute | Standard Deviation 11.51 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (24 hours) | 61.3 Beats per minute | Standard Deviation 8.5 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1 hour) | 67.5 Beats per minute | Standard Deviation 7.4 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 3 (48 hours) | 62.2 Beats per minute | Standard Deviation 12.73 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (1.5 hours) | 57.8 Beats per minute | Standard Deviation 11.2 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 1 (12 hours) | 60.7 Beats per minute | Standard Deviation 10 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 4 (Day 4 analysis only applicable for arms C,D and E) | 61.3 Beats per minute | Standard Deviation 7.55 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Baseline | 61.7 Beats per minute | Standard Deviation 8.21 |
| AZD4041 80X mg | Heart Rate at Baseline and Times Post Dose | Day 2 (36 hours) | 61.0 Beats per minute | Standard Deviation 9.6 |
Primary
Number of Adverse Events
Number of participants experiencing any adverse event
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Adverse Events | 5 Participants |
| AZD4041 X mg | Number of Adverse Events | 0 Participants |
| AZD4041 3X mg | Number of Adverse Events | 1 Participants |
| AZD4041 9X mg | Number of Adverse Events | 1 Participants |
| AZD4041 20X mg | Number of Adverse Events | 1 Participants |
| AZD4041 40X mg | Number of Adverse Events | 3 Participants |
| AZD4041 80X mg | Number of Adverse Events | 1 Participants |
Primary
Number of Participant Deaths
Number of participants who died
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participant Deaths | 0 Participants |
| AZD4041 X mg | Number of Participant Deaths | 0 Participants |
| AZD4041 3X mg | Number of Participant Deaths | 0 Participants |
| AZD4041 9X mg | Number of Participant Deaths | 0 Participants |
| AZD4041 20X mg | Number of Participant Deaths | 0 Participants |
| AZD4041 40X mg | Number of Participant Deaths | 0 Participants |
| AZD4041 80X mg | Number of Participant Deaths | 0 Participants |
Primary
Number of Participants With Abnormal 12-lead ECGs
Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 4 days
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal 12-lead ECGs | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal 12-lead ECGs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal 12-lead ECGs | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal 12-lead ECGs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal 12-lead ECGs | 1 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal 12-lead ECGs | 1 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal 12-lead ECGs | 0 Participants |
Primary
Number of Participants With Abnormal Follicle Stimulating Hormone Test Results
Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: Thru Day 4
Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Follicle Stimulating Hormone Test Results | 0 Participants |
Primary
Number of Participants With Abnormal Inhibin B Test Results
Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: Thru Day 4
Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Inhibin B Test Results | 0 Participants |
Primary
Number of Participants With Abnormal Luteinizing Hormone Test Results
Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: Thru Day 4
Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Luteinizing Hormone Test Results | 0 Participants |
Primary
Number of Participants With Abnormal Safety Laboratory Tests (Hematology)
Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Safety Laboratory Tests (Hematology) | 0 Participants |
Primary
Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)
Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry) | 0 Participants |
Primary
Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)
Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis) | 0 Participants |
Primary
Number of Participants With Abnormal Testosterone Test Results
Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: Thru Day 4
Population: Safety Analysis Set (Performed only in males recruited after protocol amendment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Testosterone Test Results | 1 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Testosterone Test Results | 0 Participants |
Primary
Number of Participants With Abnormal Vital Signs
Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Vital Signs | 2 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Vital Signs | 0 Participants |
Primary
Number of Participants With Abnormal Vital Signs (Blood Pressure)
Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 1 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Vital Signs (Blood Pressure) | 0 Participants |
Primary
Number of Participants With Abnormal Vital Signs (Heart Rate)
Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Abnormal Vital Signs (Heart Rate) | 1 Participants |
| AZD4041 X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Abnormal Vital Signs (Heart Rate) | 0 Participants |
Primary
Number of Participants With Moderate TEAEs
Number of participants experiencing any moderate TEAEs
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Moderate TEAEs | 0 Participants |
| AZD4041 X mg | Number of Participants With Moderate TEAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Moderate TEAEs | 1 Participants |
| AZD4041 9X mg | Number of Participants With Moderate TEAEs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Moderate TEAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Moderate TEAEs | 2 Participants |
| AZD4041 80X mg | Number of Participants With Moderate TEAEs | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
Number of participants experiencing any serious adverse events (SAEs)
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 9X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 20X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 40X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| AZD4041 80X mg | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants With Severe TEAEs
Number of participants experiencing any severe TEAEs
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 X mg | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 9X mg | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Severe TEAEs | 0 Participants |
| AZD4041 80X mg | Number of Participants With Severe TEAEs | 0 Participants |
Primary
Number of Participants With TEAEs Leading to Early Discontinuation
Number of participants with treatment-emergent adverse events leading to early discontinuation
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 3X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 9X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 20X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 40X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
| AZD4041 80X mg | Number of Participants With TEAEs Leading to Early Discontinuation | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants experiencing any treatment emergent adverse events
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 5 Participants |
| AZD4041 X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| AZD4041 3X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| AZD4041 9X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| AZD4041 20X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| AZD4041 40X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| AZD4041 80X mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
Primary
Number of Participants With Treatment-Related Moderate TEAEs
Number of participants experiencing any treatment-related moderate TEAEs
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Treatment-Related Moderate TEAEs | 0 Participants |
| AZD4041 X mg | Number of Participants With Treatment-Related Moderate TEAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Treatment-Related Moderate TEAEs | 1 Participants |
| AZD4041 9X mg | Number of Participants With Treatment-Related Moderate TEAEs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Treatment-Related Moderate TEAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Treatment-Related Moderate TEAEs | 1 Participants |
| AZD4041 80X mg | Number of Participants With Treatment-Related Moderate TEAEs | 0 Participants |
Primary
Number of Participants With Treatment-Related SAEs
Number of participants experiencing any treatment-related serious adverse events (SAEs)
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 9X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
| AZD4041 80X mg | Number of Participants With Treatment-Related SAEs | 0 Participants |
Primary
Number of Participants With Treatment-Related Severe TEAEs
Number of participants experiencing any treatment-related severe TEAEs
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 9X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 20X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
| AZD4041 80X mg | Number of Participants With Treatment-Related Severe TEAEs | 0 Participants |
Primary
Number of Participants With Treatment-Related TEAEs
Number of participants experiencing any treatment-related TEAEs
Time frame: 6 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Treatment-Related TEAEs | 1 Participants |
| AZD4041 X mg | Number of Participants With Treatment-Related TEAEs | 0 Participants |
| AZD4041 3X mg | Number of Participants With Treatment-Related TEAEs | 1 Participants |
| AZD4041 9X mg | Number of Participants With Treatment-Related TEAEs | 1 Participants |
| AZD4041 20X mg | Number of Participants With Treatment-Related TEAEs | 0 Participants |
| AZD4041 40X mg | Number of Participants With Treatment-Related TEAEs | 2 Participants |
| AZD4041 80X mg | Number of Participants With Treatment-Related TEAEs | 0 Participants |
Primary
Pulse Rate at Baseline and Day 1 2 Hours Post.
Measured by standing pulse rate at baseline and 2 hours post
Time frame: Baseline and Day 1
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 77.8 Beats per minute | Standard Deviation 9.53 |
| Pooled Placebo | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 81.7 Beats per minute | Standard Deviation 14.18 |
| AZD4041 X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 74.8 Beats per minute | Standard Deviation 8.45 |
| AZD4041 X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 80.2 Beats per minute | Standard Deviation 8.04 |
| AZD4041 3X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 82.2 Beats per minute | Standard Deviation 9.77 |
| AZD4041 3X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 83.7 Beats per minute | Standard Deviation 10.13 |
| AZD4041 9X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 90.7 Beats per minute | Standard Deviation 7.34 |
| AZD4041 9X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 102.8 Beats per minute | Standard Deviation 31.16 |
| AZD4041 20X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 83.5 Beats per minute | Standard Deviation 10.01 |
| AZD4041 20X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 78.2 Beats per minute | Standard Deviation 10.05 |
| AZD4041 40X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 78.2 Beats per minute | Standard Deviation 9.43 |
| AZD4041 40X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 82.0 Beats per minute | Standard Deviation 18.31 |
| AZD4041 80X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Baseline | 82.3 Beats per minute | Standard Deviation 23.95 |
| AZD4041 80X mg | Pulse Rate at Baseline and Day 1 2 Hours Post. | Day 1 (2 hours) | 90.3 Beats per minute | Standard Deviation 15.71 |
Secondary
AUC0-inf
Extrapolation of the area under the curve of AZD4041 from zero to infinity
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set. Note AUC0-inf values were excluded where AUCExtrap was \>20%
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | AUC0-inf | 192 ng·hour/mL | Geometric Coefficient of Variation 14.7 |
| AZD4041 X mg | AUC0-inf | 539 ng·hour/mL | Geometric Coefficient of Variation 35.8 |
| AZD4041 3X mg | AUC0-inf | 1660 ng·hour/mL | Geometric Coefficient of Variation 38.9 |
| AZD4041 9X mg | AUC0-inf | 5950 ng·hour/mL | Geometric Coefficient of Variation 52.4 |
| AZD4041 20X mg | AUC0-inf | 9270 ng·hour/mL | Geometric Coefficient of Variation 41 |
| AZD4041 40X mg | AUC0-inf | 14800 ng·hour/mL | Geometric Coefficient of Variation 31.6 |
Secondary
AUC0-t
Area under the curve of AZD4041 from time 0 to time t (AUC from zero to the last measurable concentration)
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | AUC0-t | 158 ng·hour/mL | Geometric Coefficient of Variation 22.8 |
| AZD4041 X mg | AUC0-t | 585 ng·hour/mL | Geometric Coefficient of Variation 49.1 |
| AZD4041 3X mg | AUC0-t | 1790 ng·hour/mL | Geometric Coefficient of Variation 29.4 |
| AZD4041 9X mg | AUC0-t | 5510 ng·hour/mL | Geometric Coefficient of Variation 45.6 |
| AZD4041 20X mg | AUC0-t | 8460 ng·hour/mL | Geometric Coefficient of Variation 34.8 |
| AZD4041 40X mg | AUC0-t | 14400 ng·hour/mL | Geometric Coefficient of Variation 27.4 |
Secondary
CL/F (Volume/Time)
Apparent total clearance of the AZD4041 from plasma
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set. Note CL/V values were excluded where AUCExtrap was \>20%.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | CL/F (Volume/Time) | 2.6 L/hour | Geometric Coefficient of Variation 14.7 |
| AZD4041 X mg | CL/F (Volume/Time) | 2.8 L/hour | Geometric Coefficient of Variation 35.8 |
| AZD4041 3X mg | CL/F (Volume/Time) | 2.7 L/hour | Geometric Coefficient of Variation 38.9 |
| AZD4041 9X mg | CL/F (Volume/Time) | 1.68 L/hour | Geometric Coefficient of Variation 52.4 |
| AZD4041 20X mg | CL/F (Volume/Time) | 2.16 L/hour | Geometric Coefficient of Variation 41 |
| AZD4041 40X mg | CL/F (Volume/Time) | 2.70 L/hour | Geometric Coefficient of Variation 31.6 |
Secondary
Cmax of AZD4041
Maximum (peak) plasma concentration of AZD4041
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Cmax of AZD4041 | 14.7 ng/mL | Geometric Coefficient of Variation 15 |
| AZD4041 X mg | Cmax of AZD4041 | 44.6 ng/mL | Geometric Coefficient of Variation 37.9 |
| AZD4041 3X mg | Cmax of AZD4041 | 154 ng/mL | Geometric Coefficient of Variation 24.7 |
| AZD4041 9X mg | Cmax of AZD4041 | 382 ng/mL | Geometric Coefficient of Variation 21.2 |
| AZD4041 20X mg | Cmax of AZD4041 | 620 ng/mL | Geometric Coefficient of Variation 25.9 |
| AZD4041 40X mg | Cmax of AZD4041 | 1060 ng/mL | Geometric Coefficient of Variation 26 |
Secondary
t1/2λz
Terminal half-life of AZD4041
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | t1/2λz | 17.9 hour | Geometric Coefficient of Variation 19 |
| AZD4041 X mg | t1/2λz | 13.0 hour | Geometric Coefficient of Variation 40.5 |
| AZD4041 3X mg | t1/2λz | 19.9 hour | Geometric Coefficient of Variation 44.7 |
| AZD4041 9X mg | t1/2λz | 17.9 hour | Geometric Coefficient of Variation 37.9 |
| AZD4041 20X mg | t1/2λz | 19.8 hour | Geometric Coefficient of Variation 33.3 |
| AZD4041 40X mg | t1/2λz | 16.0 hour | Geometric Coefficient of Variation 22.8 |
Secondary
Tmax of AZD4041
Time to reach maximum (peak) plasma concentration of AZD4041
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pooled Placebo | Tmax of AZD4041 | 0.50 hour |
| AZD4041 X mg | Tmax of AZD4041 | 1.00 hour |
| AZD4041 3X mg | Tmax of AZD4041 | 0.50 hour |
| AZD4041 9X mg | Tmax of AZD4041 | 1.00 hour |
| AZD4041 20X mg | Tmax of AZD4041 | 1.00 hour |
| AZD4041 40X mg | Tmax of AZD4041 | 1.00 hour |
Secondary
Vss/F (Plasma)
Apparent volume of distribution of AZD4041 at steady state
Time frame: Thru Day 4
Population: Pharmacokinetic Analysis Set. Note Vss/F values were excluded where AUCExtrap was \>20%.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Vss/F (Plasma) | 68.8 L | Geometric Coefficient of Variation 4.2 |
| AZD4041 X mg | Vss/F (Plasma) | 45.4 L | Geometric Coefficient of Variation 26.2 |
| AZD4041 3X mg | Vss/F (Plasma) | 56.0 L | Geometric Coefficient of Variation 22.9 |
| AZD4041 9X mg | Vss/F (Plasma) | 43.3 L | Geometric Coefficient of Variation 22.1 |
| AZD4041 20X mg | Vss/F (Plasma) | 61.7 L | Geometric Coefficient of Variation 22.1 |
| AZD4041 40X mg | Vss/F (Plasma) | 57.2 L | Geometric Coefficient of Variation 24.3 |