A Food Effect Study of TAK-385 Final Formulation
Condition: Japanese Premenopausal Healthy Adult Women
Intervention: TAK-385 40 mg
Intervention description: TAK-385 40 mg tablet
Intervention MeSH terms: Relugolix
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate food effects on the pharmacokinetics of a single
      oral dose of TAK-385 in Japanese premenopausal healthy adult women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form prior to the
             initiation of any study procedures.

          3. The participant is a Japanese premenopausal healthy adult woman.

          4. The participant is aged 20 to 45 years, inclusive, at the time of informed consent.

          5. The participant weighs at least 40.0 kilogram (kg) and has a body mass index (BMI)
             from 18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive at Screening.

          6. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to routinely use adequate contraception from the
             time of signing the informed consent form throughout the duration of the study.

          7. The participant has experienced 3 or more consecutive regular menstrual cycles prior
             to the time of informed consent.

        Exclusion Criteria:

          1. The participant has received any investigational compound within 16 weeks (112 days)
             prior to the first dose of study drug in Period 1.

          2. The participant has received TAK-385 in a previous clinical study.

          3. The participant is an immediate family member, study site employee, or is in a
             dependent relationship with a study site employee who is involved in the conduct of
             this study (example, spouse, parent, child, sibling) or may consent under duress.

          4. The participant has uncontrolled, clinically significant neurological, circulatory,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary, or endocrine disease,
             or other abnormality, which may impact the ability of the participant to participate
             in the study or potentially confound the study results.

          5. The participant has a diagnosis of abnormal menstruation.

          6. The participant has undiagnosable abnormal genital bleeding.

          7. The participant has a known hypersensitivity or allergy to drugs.

          8. The participant has a positive urine drug test result for drug abuse or positive
             breath alcohol test result at Screening.

          9. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 1 year prior to the screening visit or is unwilling to
             agree to abstain from alcohol and drugs throughout the study.

         10. The participant has taken any excluded medication, supplements, or food products
             during the time periods listed in the Prohibited Medications and Dietary Products
             table.

         11. The participant has used oral contraceptive or sex hormone preparations
             (norethindrone, norethisterone, medroxyprogesterone, estrogen, or other progestins)
             within 8 weeks (56 days) prior to hospitalization in Period 1 (Day -1), or
             gonadotropin-releasing hormone (GnRH) analogues, dienogest, danazol, or aromatase
             inhibitors within 16 weeks (112 days) prior to hospitalization in Period 1 (Day -1)
             [within 20 weeks (140 days) and 28 weeks (196 days) prior to hospitalization for 1-
             and 3-month sustained preparations, respectively].

         12. The participant is pregnant or lactating or intending to become pregnant before the
             time of informed consent, during the study, or within 1 month after completing in this
             study; or intending to donate ova during such time period.

         13. The participant has evidence of current cardiovascular disease, central nervous system
             disease, hepatic disease, hematopoietic disease, renal dysfunction, metabolic or
             endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension,
             thromboembolism, seizures, allergic skin rash, gastrointestinal disease
             (pseudomembranous colitis), or mental disorder (especially depression-like symptoms)
             and resultant suicide attempt. The participant has a medical history, physical
             examination finding, or safety laboratory test finding reasonably indicative of a
             disease that would contraindicate GnRH analogues, or may interfere with the conduct of
             the study. This includes, but is not limited to, peptic ulcer disease, seizure
             disorders, and cardiac arrhythmias.

         14. The participant has current or recent (within 6 months) gastrointestinal disease that
             may influence the absorption of drugs (that is, malabsorption, esophageal reflux,
             peptic ulcer disease, erosive esophagitis, frequent heartburn, or any surgical
             intervention).

         15. The participant has a history of cancer.

         16. The participant has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody,
             or serological reactions for syphilis at Screening.

         17. The participant has used nicotine-containing products (including but not limited to
             cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28
             days prior to hospitalization in Period 1 (Day -1), or is unwilling to agree to stop
             using these products throughout the study.

         18. The participant has poor peripheral venous access.

         19. The participant has undergone whole blood collection of at least 200 milliliter (mL)
             within 4 weeks (28 days) or at least 400 mL within 16 weeks (112 days) prior to the
             start of study drug administration in Period 1.

         20. The participant has undergone whole blood collection of at least 400 mL in total
             within 52 weeks (364 days) prior to the start of study drug administration in Period
             1.

         21. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of study drug administration in Period 1.

         22. The participant has a clinically significant abnormal electrocardiogram (ECG) at
             Screening or prior to study drug administration in Period 1.

         23. The participant has abnormal laboratory values that suggest a clinically significant
             underlying disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase
             (AST) greater than (>)1.5 the upper limits of normal at Screening or prior to study
             drug administration in Period 1.

         24. The participant who, in the opinion of the investigator, is unlikely to comply with
             the protocol or is unsuitable for any other reason.