Clinical trial: A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers (NCT04478513)

Eligibility criteria:
Inclusion Criteria:

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures.

          -  Healthy male and female subjects of non-childbearing potential subjects aged 18 - 55
             years (inclusive at screening) with suitable veins for cannulation or repeated
             venipuncture.

          -  Have a body mass index (BMI) between 18.5 and 32.0 kg/m2 inclusive and weigh at least
             50 kg and no more than 100 kg, inclusive.

          -  Willingness and ability to comply with study and follow-up procedures.

          -  Subjects who are recruited as non-smokers should have no history of smoking cigarettes
             for >6 months and test negative for urine cotinine levels at screening and admission.

          -  Subjects who are recruited as smokers must have a history of smoking >10
             cigarettes/day for >6 months and have urine cotinine levels over 500 ng/ml at
             screening and admission.

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder which, in the opinion of the
             principal investigator (PI), may either put the volunteer at risk because of
             participation in the study, or influence the results or the volunteer's ability to
             participate in the study.

          -  History or presence of gastrointestinal (GI), hepatic or renal disease, or any other
             condition known to interfere with absorption, distribution, metabolism, or excretion
             of drugs.

          -  History of cardiac disease; concurrent electroconvulsive therapy, diabetes mellitus,
             epilepsy, bleeding disorders (especially GI bleeding), mania and susceptibility to
             angle-closure glaucoma.

          -  Presence of refractory nausea and vomiting or chronic GI diseases.

          -  Any clinically significant illness, medical/surgical procedure, or trauma within 4
             weeks of the first administration of investigational medicinal product (IMP).

          -  Any clinically significant abnormalities in clinical chemistry, haematology, or
             urinalysis results, as judged by the PI (based on laboratory parameters).

          -  Any clinically significant abnormal findings in vital signs at screening as judged by
             the PI.

          -  Systolic blood pressure (BP) >140 and/or diastolic BP > 90 mmHg, or history of
             hypertension at screening.

          -  Any confirmed clinically significant abnormalities on 12-lead ECG at screening, as
             judged by the PI.

          -  Haemoglobin A1c (HbA1c) >5.7% at the screening visit.

          -  Any positive result on screening for serum hepatitis B surface antigen, hepatitis C
             antibody, and human immunodeficiency virus (HIV) antibodies.

          -  Known or suspected history of drug abuse, within the past 2 years, as judged by the
             PI.

          -  Has received another new chemical entity (defined as a compound which has not been
             approved for marketing) within 3 months of the first administration of IMP in this
             study.

          -  Plasma donation within 1 month of screening or any blood donation/loss more than 500
             mL during the 3 months prior to screening.

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
             judged by the PI.

          -  Positive screen for drugs of abuse at screening or admission to the study centre.

          -  Use of herbal preparations/medications within 14 days prior to the administration of
             the first dose of AZD4635.

          -  Subject who has had prescription or non-prescription drugs or other products known to
             be sensitive to Breast cancer resistance protein.

          -  Use of any prescribed or non prescribed medication including antacids, analgesics,
             herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily
             dose) and minerals during the 2 weeks prior to the first administration of IMP.

          -  Subjects who have involvement with AstraZeneca or Parexel or are study site employee
             or their close relatives.

          -  Subjects who have previously been enrolled in this study or have previously received
             AZD4635.

          -  Judgment by the PI that the subject should not participate in the study if they have
             any ongoing or recent (i.e., 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 1