A Phase 1, Food Effect Study of TAK-385 Final Formulatio

Phase 1

• Conditions: Japanese premenopausal healthy adult women

• Registration Number: JPRN-jRCT2080223218
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 35

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 kg and has a body mass index (BMI) from 18.5 to 25.0 kg/m^2, inclusive at Screening.
6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent 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 medication 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 (eg, spouse, parent, child, sibling) or may consent under duress.
4. The participant has uncontrolled, clinically significant neurologic, 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 Excluded 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 (ie, 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) antig

Study & Design

• Study Type: Interventional
• Study Design: Not specified