Clinical trial NCT02792062: A Food Effect Study of TAK-385 Final Formulation
Official title: A Phase 1, Randomized, Open-label, Crossover Study to Assess Food Effect on Single Oral Dose Administration of TAK-385 Final Formulation in Premenopausal Healthy Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Japanese Premenopausal Healthy Adult Women
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a phase 1 clinical pharmacological study of TAK-385 in Japanese premenopausal healthy adult women.

Using an open-label crossover design, food effects on the pharmacokinetics and safety of TAK-385 will be evaluated in participants receiving a single oral dose of TAK-385 40 mg in fasted condition without breakfast, before breakfast, or after breakfast.

Participants determined to be eligible will be randomly assigned to one of Groups A to F prior to study medication administration in Period 1; subsequently, participants will receive one TAK-385 40 mg tablet in fasted condition without breakfast (following a minimum 10-hour overnight fast), before breakfast (30 minutes before starting breakfast), or after breakfast (30 minutes after starting breakfast) in Periods 1, 2, and 3.

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.

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for TAK-385
timeFrame: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
timeFrame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
measure: AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
timeFrame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
timeFrame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose
Secondary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
timeFrame: Day 1 up to 12 days after the last dose of study drug (Day 41)
measure: Number of Participants With TEAEs Related to Vital Signs (Presyncope)
timeFrame: Day 1 up to 12 days after last dose of study drug (Day 41)
measure: Number of Participants With TEAEs Related to Body Weight
timeFrame: Day 1 up to 12 days after last dose of study drug (Day 41)
measure: Number of Participants With TEAEs Related to Electrocardiograms (ECG)
timeFrame: Day 1 up to 12 days after last dose of study drug (Day 41)
measure: Number of Participants With TEAEs Related to Clinical Laboratory Tests
timeFrame: Day 1 up to 12 days after last dose of study drug (Day 41)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
state: Fukuoka
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: