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Healthy postmenopausal female volunteers will be included in the study if they meet all of |
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the following criteria |
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Part A- |
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Healthy postmenopausal female subjects, aged > 18 years, Weight over 50 kg and with a |
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body mass index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part |
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Part B and C- |
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Did not donate 50-349 mL blood within 30 days or ≥350 mL blood within 3 months prior |
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to IMP administration and agrees not to make blood donations, including red blood |
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cells, plasma, platelets, or whole blood for the entire study duration |
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Healthy male and postmenopausal female subjects, aged ≥ 18 years, with a body mass |
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index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part |
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Did not donate 50-499 mL blood within 30 days or ≥500 mL blood within 56 days prior to |
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IMP administration and agrees not to make blood donations, including red blood cells |
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plasma, platelets, or whole blood for the entire study duration |
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Men who are able to father children must agree to use medically acceptable methods of |
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contraception and NOT donate sperm during the study and for 90 days after the end of |
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the study. Medically acceptable methods of contraception include using a condom with a |
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female partner of child-bearing potential who is using oral contraceptives, hormonal |
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patch, implant or injection, intrauterine device, or diaphragm with spermicide |
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Abstinence as a method of contraception is acceptable if it is in line with the |
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preferred and usual lifestyle of the study participant |
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All parts- |
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Willing and able to give written, signed and dated informed consent (or by subject's |
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legally acceptable representative/impartial witness when applicable) and is available |
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for the entire study |
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Willing and able to comply with the scheduled visits, treatment plan, laboratory |
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testing, study procedures, and restrictions (as per section 4.5), and be accessible |
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for follow-up visits |
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Assessed as healthy based on no clinically significant abnormality identified on |
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medical history, physical examination, vital signs, electrocardiogram (ECG), and |
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clinical laboratory screening tests |
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Females who are naturally postmenopausal for at least 12 consecutive months with a |
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follicle-stimulating hormone level of ≥ 40 mIU/mL at screening |
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Non-smokers or abstain from any tobacco usage, including smokeless tobacco, nicotine |
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patches, etc. for entire study duration including screening period; subjects must have |
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urine cotinine levels below those measured for smokers (< 200 ng/mL) |
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Inability to swallow oral medication
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Inability to undergo venipuncture and/or tolerate venous access
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Subjects will be excluded from the Study if they meet any of the following criteria: (All
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Parts)
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Any major surgery, as determined by the Investigator, within 4 weeks of IMP
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administration
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Blood transfusion within 4 weeks prior to IMP administration
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Female on Hormone Replacement Therapy, or having been on the same in the past 6
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months
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Active liver disease or history of liver disease (such as hepatitis) in the past 6
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Subjects with complaints of hot flashes at screening
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months which can have impact on study endpoints and/ safety of subjects as per
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investigator discretion
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Medical history of thromboembolic disorders or with risks (such as hematologic or
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rheumatologic disorders); recent history of thrombophlebitis
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History of abnormal vaginal bleeding within 3 months prior to screening and/ or
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uterine malignancy
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Positive exclusion tests: human immunodeficiency virus (HIV), hepatitis B surface
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antigen, or hepatitis C virus
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History of any relevant allergy/hypersensitivity (including known immediate or delayed
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hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or
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its excipients)
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Received another investigational agent within 30 days (or for investigational agents
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with long half life a washout of 5 half-lives will be required) prior to IMP
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administration or intake of an investigational drug during the course of this study
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Intake of any prescribed medication/drugs within at least 14 days and/or
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over-the-counter drugs within at least 7 days (or less than 5 half-lives of the
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respective drug) prior to administration of the IMP
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Known and/ or suspected history of significant drug abuse as judged by the
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Investigator
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Positive screen for drugs of abuse at Screening visit or positive screen for alcohol
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or drugs of abuse on admission to the study centre prior to the first IMP
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administration
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History of alcohol abuse or excessive intake of alcohol, defined as regular weekly
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intake of more than 15 units of alcohol (Note: 1 unit equals 25 mL spirits, 125 mL
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wine, or 250 mL beer or lager) in the 12 months prior to study entry
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Current or recent disease of the gastrointestinal tract that may impact drug
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absorption and may affect the PK of the IMP, or any gastrointestinal tract surgery
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history that may impact drug absorption
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Continued use of caffeine or grapefruit juice or xanthine-containing drinks or food
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e.g., coffee, tea, chocolate, red bull, or cola for 48 hours prior to dosing and till
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the last PK sample collection
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Any concomitant clinically significant disorder, like infection, diabetes etc. that
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would pose a risk to subject safety or interfere with the study evaluation
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procedures, or completion which can have impact on study endpoints and/ safety of
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subjects as per PI discretion
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