Japanese Premenopausal Healthy Adult Women
Conditions
Keywords
Drug therapy
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.
Interventions
DRUGTAK-385 40 mg
TAK-385 40 mg tablet
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-385 | Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | 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 |
| AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385 | 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 |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | Day 1 up to 12 days after the last dose of study drug (Day 41) | — |
| Number of Participants With TEAEs Related to Vital Signs (Presyncope) | Day 1 up to 12 days after last dose of study drug (Day 41) | — |
| Number of Participants With TEAEs Related to Body Weight | Day 1 up to 12 days after last dose of study drug (Day 41) | — |
| Number of Participants With TEAEs Related to Electrocardiograms (ECG) | Day 1 up to 12 days after last dose of study drug (Day 41) | — |
| Number of Participants With TEAEs Related to Clinical Laboratory Tests | Day 1 up to 12 days after last dose of study drug (Day 41) | Clinical laboratory tests included hematology, serum chemistry, and urinalysis. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 04 July 2016 to 31 August 2016.
Pre-assignment details
Healthy premenopausal adult female participants were enrolled and randomized in this 3 period cross over study in 1 of 6 administration sequences to receive TAK-385 40 milligram (mg) under fasted conditions without breakfast, before breakfast, or after breakfast.
Participants by arm
| Arm | Count |
|---|---|
| TAK-385: Fasted+ Before Breakfast + After Breakfast TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hour (hr) overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3. | 2 |
| TAK-385: Before Breakfast+ After Breakfast + Fasted TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3. | 2 |
| TAK-385: After Breakfast+ Fasted + Before Breakfast TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3. | 2 |
| TAK-385: Fasted+ After Breakfast + Before Breakfast TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 3. | 2 |
| TAK-385: Before Breakfast+ Fasted + After Breakfast TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 3. | 2 |
| TAK-385: After Breakfast+ Before Breakfast + Fasted TAK-385 40 mg, tablet, orally, after 30 minutes of taking breakfast once on Day 1 of intervention period 1, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, before 30 minutes of taking breakfast once on Day 1 of intervention period 2, followed by a minimum 14-day washout period between study drug, further followed by TAK-385 40 mg, tablet, orally, under fasted conditions without breakfast following a minimum 10-hr overnight fast once on Day 1 of intervention period 3. | 2 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Washout Period (at Least 14 Days) | Voluntary Withdrawal | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | TAK-385: After Breakfast+ Before Breakfast + Fasted | TAK-385: Before Breakfast+ Fasted + After Breakfast | TAK-385: Fasted+ After Breakfast + Before Breakfast | TAK-385: After Breakfast+ Fasted + Before Breakfast | TAK-385: Fasted+ Before Breakfast + After Breakfast | TAK-385: Before Breakfast+ After Breakfast + Fasted |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 7.34 | 23.0 years STANDARD_DEVIATION 4.24 | 31.5 years STANDARD_DEVIATION 13.44 | 29.0 years STANDARD_DEVIATION 2.83 | 33.0 years STANDARD_DEVIATION 12.73 | 26.5 years STANDARD_DEVIATION 4.95 | 25.0 years STANDARD_DEVIATION 7.07 |
| Alcohol Classification Drinks a few days per month | 7 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants |
| Alcohol Classification Drinks a few days per week | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Alcohol Classification Never drinks | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) | 20.73 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.213 | 21.00 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0.566 | 21.70 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0 | 19.30 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0 | 19.40 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0.99 | 22.20 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0.707 | 20.75 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 0.636 |
| Caffeine Consumption Caffeine consumption | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Caffeine Consumption No caffeine consumption | 7 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants |
| Height | 156.0 centimeter (cm) STANDARD_DEVIATION 3.59 | 155.0 centimeter (cm) STANDARD_DEVIATION 7.07 | 156.0 centimeter (cm) STANDARD_DEVIATION 0 | 155.0 centimeter (cm) STANDARD_DEVIATION 0 | 156.0 centimeter (cm) STANDARD_DEVIATION 4.24 | 153.5 centimeter (cm) STANDARD_DEVIATION 2.12 | 160.5 centimeter (cm) STANDARD_DEVIATION 3.54 |
| Region of Enrollment Japan | 12 participants | 2 participants | 2 participants | 2 participants | 2 participants | 2 participants | 2 participants |
| Sex/Gender, Customized Female | 12 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants |
| Smoking Classification Ex-smoker | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Smoking Classification Never smoked | 10 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants |
| Weight | 50.60 kilogram (kg) STANDARD_DEVIATION 3.98 | 50.70 kilogram (kg) STANDARD_DEVIATION 5.94 | 52.95 kilogram (kg) STANDARD_DEVIATION 0.071 | 46.45 kilogram (kg) STANDARD_DEVIATION 0.071 | 47.50 kilogram (kg) STANDARD_DEVIATION 4.95 | 52.45 kilogram (kg) STANDARD_DEVIATION 3.041 | 53.55 kilogram (kg) STANDARD_DEVIATION 4.031 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 12 | 5 / 12 | 3 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 11 |
Outcome results
Primary
AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385
Time frame: 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
Population: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 40 mg Fasted | AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385 | 149.3 ng*hr/mL | Standard Deviation 70.354 |
| TAK-385 40 mg Before Breakfast | AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385 | 130.2 ng*hr/mL | Standard Deviation 61.549 |
| TAK-385 40 mg After Breakfast | AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385 | 73.25 ng*hr/mL | Standard Deviation 30.726 |
Comparison: Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).p-value: 0.25690% CI: [66.23, 108.27]Mixed Models Analysis
Comparison: Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).p-value: <0.00190% CI: [40.78, 67.74]Mixed Models Analysis
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Time frame: 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
Population: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 40 mg Fasted | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | 160.5 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 75.187 |
| TAK-385 40 mg Before Breakfast | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | 139.1 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 65.653 |
| TAK-385 40 mg After Breakfast | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | 79.65 nanogram*hour per milliliter (ng*hr/mL) | Standard Deviation 33.426 |
Comparison: Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).p-value: 0.23890% CI: [66.09, 107.47]Mixed Models Analysis
Comparison: Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).p-value: <0.00190% CI: [41.39, 68.37]Mixed Models Analysis
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385
Time frame: 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
Population: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 40 mg Fasted | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385 | 149.3 ng*hr/mL | Standard Deviation 70.354 |
| TAK-385 40 mg Before Breakfast | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385 | 130.2 ng*hr/mL | Standard Deviation 61.549 |
| TAK-385 40 mg After Breakfast | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385 | 73.25 ng*hr/mL | Standard Deviation 30.726 |
Comparison: Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).p-value: 0.25690% CI: [66.23, 108.27]Mixed Models Analysis
Comparison: Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).p-value: <0.00190% CI: [40.78, 67.74]Mixed Models Analysis
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-385
Time frame: Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose
Population: The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 40 mg Fasted | Cmax: Maximum Observed Plasma Concentration for TAK-385 | 23.44 nanogram per milliliter (ng/mL) | Standard Deviation 17.822 |
| TAK-385 40 mg Before Breakfast | Cmax: Maximum Observed Plasma Concentration for TAK-385 | 29.05 nanogram per milliliter (ng/mL) | Standard Deviation 22.868 |
| TAK-385 40 mg After Breakfast | Cmax: Maximum Observed Plasma Concentration for TAK-385 | 10.94 nanogram per milliliter (ng/mL) | Standard Deviation 9.3726 |
Comparison: Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).p-value: 0.65990% CI: [70.37, 181.67]Mixed Models Analysis
Comparison: Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).p-value: 0.01290% CI: [27.86, 74.07]Mixed Models Analysis
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.
Time frame: Day 1 up to 12 days after the last dose of study drug (Day 41)
Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-385 40 mg Fasted | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | TEAEs | 5 participants |
| TAK-385 40 mg Fasted | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | Serious TEAEs | 0 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | TEAEs | 5 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | Serious TEAEs | 0 participants |
| TAK-385 40 mg After Breakfast | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | TEAEs | 3 participants |
| TAK-385 40 mg After Breakfast | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs. | Serious TEAEs | 0 participants |
Secondary
Number of Participants With TEAEs Related to Body Weight
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 40 mg Fasted | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants With TEAEs Related to Body Weight | 0 participants |
| TAK-385 40 mg After Breakfast | Number of Participants With TEAEs Related to Body Weight | 0 participants |
Secondary
Number of Participants With TEAEs Related to Clinical Laboratory Tests
Clinical laboratory tests included hematology, serum chemistry, and urinalysis.
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 40 mg Fasted | Number of Participants With TEAEs Related to Clinical Laboratory Tests | 0 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants With TEAEs Related to Clinical Laboratory Tests | 0 participants |
| TAK-385 40 mg After Breakfast | Number of Participants With TEAEs Related to Clinical Laboratory Tests | 0 participants |
Secondary
Number of Participants With TEAEs Related to Electrocardiograms (ECG)
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 40 mg Fasted | Number of Participants With TEAEs Related to Electrocardiograms (ECG) | 0 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants With TEAEs Related to Electrocardiograms (ECG) | 0 participants |
| TAK-385 40 mg After Breakfast | Number of Participants With TEAEs Related to Electrocardiograms (ECG) | 0 participants |
Secondary
Number of Participants With TEAEs Related to Vital Signs (Presyncope)
Time frame: Day 1 up to 12 days after last dose of study drug (Day 41)
Population: The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 40 mg Fasted | Number of Participants With TEAEs Related to Vital Signs (Presyncope) | 0 participants |
| TAK-385 40 mg Before Breakfast | Number of Participants With TEAEs Related to Vital Signs (Presyncope) | 1 participants |
| TAK-385 40 mg After Breakfast | Number of Participants With TEAEs Related to Vital Signs (Presyncope) | 0 participants |