A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers

Inclusion criteria

• 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.
• Provision of signed and dated, written Informed Consent Form prior to any mandatory study specific procedures, sampling, and analyses.
• Subjects must be ≥18 and less than or equal to 65 years of age at the time of signing the Informed Consent Form.
• Individuals who are healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Individuals who weigh ≥50 kg and who have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
• Either male or female.
• Female subjects must have a negative pregnancy test result at screening and check-in and, on admission to the unit, must not be lactating.
• Female subjects must be of non-childbearing potential, as confirmed at screening by fulfilling one of the following criteria:
• 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.
• 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.
• Male subjects must be vasectomized.

Exclusion criteria

• 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.
• 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.
• Male subjects with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
• Subjects who are undergoing treatment or evaluation for infertility.
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of administration of Investigational Product.
• Any clinically important abnormalities noted at the screening assessments in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus antibodies.
• Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
• Systolic BP 85 beats per minute.
• 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.
• 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.
• ECG interval measured from the onset of the P wave to the onset of the QRS complex (PR[PQ]) interval shortening 110 ms but 240 ms), persistent or intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation.
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