Hormone Treatment-naïve Participants With Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.
Detailed description
The objective of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naive participants with non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising (MRD) phase and Part B, an expansion phase.
Interventions
DRUGTAK-385
TAK-385 Tablets.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants judged by the investigator to have the capacity to understand the study and follow the study rules. 2. Participants whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed. 3. Japanese male participants 20 or more years of age at the time of informed consent. 4. Participants who, if they have a female partner who could become pregnant, agree to practice appropriate means of contraception from the time of informed consent throughout the entire study treatment period and for 4 months after the last dose of study drug. 5. Participants in stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks (28 days) prior to study treatment initiation. 6. Participants with histologically or cytologically confirmed prostate cancer. 7. Participants whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for participants who have undergone radical prostatectomy. 8. Participants who are considered eligible for hormone therapy for prostate cancer. 9. Participants who have not received hormone therapy (example, gonadotropin-releasing hormone \[GnRH\] agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer. 10. Participants who have not undergone surgical castration. 11. Participants with serum testosterone at screening greater than (\>) 150 nanogram per deciliter (ng/dL). 12. Participants meeting either of the following criteria for prostate-specific antigen (PSA) at screening. Untreated prostate cancer: PSA at screening \> 4.0 nanogram per milliliter (ng/mL) Treated\* prostate cancer: PSA at screening \> 0.2 ng/mL. * Participants who have undergone prostatectomy or either or both of high intensity focused ultrasound therapy or radiotherapy (excluding 125I-brachytherapy) prior to the start of this study. 13. Eastern Cooperative Oncology Group (ECOG) Performance Status \[17\] of 0 or 1. 14. Body mass index (BMI) at screening greater than or equal to (\>=) 18.0 kilogram per square meter (kg/m\^2).
Exclusion criteria
1. Participants exhibiting symptoms judged related to prostate cancer by the investigator (example, bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy. 2. Participants who have received 5-alpha reductase inhibitors (except for participants who have been treated for male-pattern alopecias). 3. Participants who have received chemotherapy for prostate cancer (including estramustine). 4. Participants who have received 125I-brachytherapy. 5. Participants who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation. 6. Participants who underwent prostatectomy within 16 weeks (112 days before study treatment initiation. 7. Treatment with any investigational compound within the 4 weeks (28 days) prior to the first dose of study drug or ongoing participation in another experimental trial related to the treatment of prostate cancer. 8. Diagnosis or treatment for another systemic malignancy within 2 years before study treatment initiation, or who had received a diagnosis of another malignancy before that and have evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ who have undergone complete resection will not be excluded from the study. 9. Participants taking drugs with moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitory or inducing effects, or any medications, supplements, or food products with P-glycoprotein (P-gp) inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation. 10. Participants who have received TAK-385 in a past clinical study. 11. Participants for whom it would be difficult to collect blood from a peripheral vein. 12. Participants with uncontrolled and clinically significant nervous, circulatory, pulmonary, hepatic, renal, metabolic, gastrointestinal, urogenital, or endocrine disorders, or other abnormalities (except for the targeted disease) that could affect study participation or the study results. Also, participants meeting any of criteria a through c below. A. Participants with uncontrolled diabetes (Hemoglobin A1c \[HbA1C\] \> 8 percent \[%\] at screening). However, participants whose HbA1c is brought under control with diabetes medications may be rescreened. B. Participants with uncontrolled hypertension (systolic blood pressure \> 150 millimeter of mercury (mmHg) and diastolic blood pressure \> 90 mmHg at 2 separate measurements taken no more than 60 minutes apart at screening). Participants whose blood pressure is brought under control by antihypertensive medication may be rescreened. C. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, arrhythmias of common terminology criteria for adverse events (CTCAE) Grade \> 2, thromboembolism (deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other heart diseases (example, pericardial effusion, restrictive cardiomyopathy). However, chronic stable atrial fibrillation controlled by stable anticoagulant therapy will be allowed. 13. Participants with bilateral hydronephrosis or bladder neck outlet obstruction. 14. Known hypersensitivity to TAK-385, TAK-385 excipients, or gonadotropin-releasing hormone (GnRH) antagonists. 15. Participants with a past history of gastrointestinal tract treatments (including gastrectomy) or gastrointestinal disease that could affect the drug absorption or tolerability (malabsorption, esophageal reflux, peptic ulcer, erosive esophagitis). 16. Participants positive for hepatitis B surface antigens (HBsAg), hepatitis C antibodies (HCV), human immunodeficiency virus (HIV) antibodies, or serologic test for syphilis, or with life-threatening disease other than cancer, at screening. 17. Clinically relevant electrocardiogram (ECG) abnormalities, or the following ECG abnormalities, at screening. * Q-wave infarction, unless identified 6 or more months prior to TAK-385 treatment initiation. * QTcF interval \> 450 millisecond (msec) (when calculating the QTc interval, Fridericia's equation \[QT/RR0.33\] will be used). 18. Participants with congenital QT prolongation. 19. Current use of Class 1A or Class 3 antiarrhythmic medications. 20. New York Heart Association Class III or IV heart failure. 21. Participants with clinical laboratory abnormalities suggesting clinically relevant underlying disease, or with any of the following abnormal results, at screening. * Serum creatinine \>= 2.0 mg/dL. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 1.5\*upper limit of normal (ULN) for the study site. * Total bilirubin \>= 2\*ULN for the study site. * Neutrophil count less than (\<) 1,500 per cubic millimeter (/mm\^3), platelet count \< 100,000 per microliter (/mcL), hemoglobin \< 10.0 g/dL. * Results of heart-related tests (creatine kinase MB \[CK-MB\] and cardiac troponin T) exceeding the study sites reference value. 22. Participants found to have clinical problems on the basis of examination findings, ECG findings, or chest X-ray findings at screening. 23. Participants considered unlikely by investigators to be able to follow the study protocol or considered ineligible for the study by investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | From treatment initiation until 40 days after last dose of study drug (Day 712) | — |
| Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | From treatment initiation until 40 days after last dose of study drug (Day 68) | Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. |
| Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | From treatment initiation until 40 days after last dose of study drug (Day 68) | — |
| Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | From treatment initiation until 40 days after last dose of study drug (Day 68) | — |
| Part B: Number of Participants Reporting One or More TEAE | From treatment initiation until 40 days after last dose of study drug (Day 712) | — |
| Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | From treatment initiation until 40 days after last dose of study drug (Day 712) | Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase \[GOT\]) High, creatine kinase (CK) (creatine phosphokinase \[CPK\]) High, prothrombin time (PT)-international normalized ratio (INR) High. |
| Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | From treatment initiation until 40 days after last dose of study drug (Day 712) | Here BP is blood pressure. |
| Part A: Number of Participants With Dose-limiting Toxicities (DLTs) | From treatment initiation until Day 28 | DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose. |
| Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | From treatment initiation until 40 days after last dose of study drug (Day 68) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose |
| Part A: Serum Testosterone Concentrations for TAK-385 | Up to Day 35 |
| Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) | Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1) |
| Part B: Plasma Concentration of Unchanged TAK-385 | Up to Week 49 Day 1 |
| Part B: Serum Testosterone Concentrations for TAK-385 | Up to Week 97 Day 1 |
| Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 7 investigative sites in Japan from 01 May 2014 to 20 April 2017.
Pre-assignment details
Japanese participants with hormone treatment-naive prostate cancer were enrolled in this study to receive TAK-385 loading dose (320 or 360 milligram \[mg\]) and maintenance dose (80, 120 or 160 mg) in two parts: Part A, dose-escalation phase, cohorts 1-4 and Part B, dose-expansion phase, cohorts 1-2.
Participants by arm
| Arm | Count |
|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | 3 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | 4 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | 3 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | 3 |
| Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | 15 |
| Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | 15 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Major Protocol Deviation | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Pretreatment Event/ Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 72.0 years STANDARD_DEVIATION 5.6 | 75.0 years STANDARD_DEVIATION 6.08 | 71.7 years STANDARD_DEVIATION 3.51 | 74.5 years STANDARD_DEVIATION 4.84 | 74.4 years STANDARD_DEVIATION 5.53 | 73.3 years STANDARD_DEVIATION 5.51 | 74.0 years STANDARD_DEVIATION 5 |
| Body Mass Index (BMI) | 23.03 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.841 | 22.00 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.4 | 22.17 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.498 | 24.17 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.109 | 21.93 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.475 | 22.90 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.1 | 22.90 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.694 |
| Height | 167.0 centimeter (cm) STANDARD_DEVIATION 3.92 | 162.3 centimeter (cm) STANDARD_DEVIATION 3.06 | 160.3 centimeter (cm) STANDARD_DEVIATION 4.16 | 163.4 centimeter (cm) STANDARD_DEVIATION 3.94 | 164.7 centimeter (cm) STANDARD_DEVIATION 5.27 | 166.0 centimeter (cm) STANDARD_DEVIATION 5.57 | 164.1 centimeter (cm) STANDARD_DEVIATION 4.57 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | 0 Participants |
| Region of Enrollment Japan | 4 participants | 3 participants | 3 participants | 15 participants | 15 participants | 3 participants | 43 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 3 Participants | 15 Participants | 15 Participants | 3 Participants | 43 Participants |
| Weight | 64.40 kilogram (kg) STANDARD_DEVIATION 9.542 | 57.97 kilogram (kg) STANDARD_DEVIATION 2.857 | 56.80 kilogram (kg) STANDARD_DEVIATION 1.992 | 64.43 kilogram (kg) STANDARD_DEVIATION 7.891 | 59.34 kilogram (kg) STANDARD_DEVIATION 5.44 | 63.27 kilogram (kg) STANDARD_DEVIATION 8.361 | 61.59 kilogram (kg) STANDARD_DEVIATION 7.017 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 3 | 2 / 4 | 3 / 3 | 2 / 3 | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 3 | 0 / 3 | 3 / 15 | 3 / 15 |
Outcome results
Primary
Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 2 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 2 Participants |
Primary
Part A: Number of Participants With Dose-limiting Toxicities (DLTs)
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose.
Time frame: From treatment initiation until Day 28
Population: The DLT analysis set included all participants enrolled in cohort A that meeting the following; who had taken at least 80 percent (%) of the doses of TAK-385 (23 doses) during the DLT evaluation period and for whom the DLT evaluation period observations had been completed or who had experienced DLTs during the DLT evaluation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 Participants |
Primary
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 0 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 1 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 1 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 1 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 0 Participants |
Primary
Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | Heart Rate <50 bpm | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | QT Interval >=460 millisecond (msec) | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | QT Interval >=460 millisecond (msec) | 2 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | Heart Rate <50 bpm | 2 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | Heart Rate <50 bpm | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | QT Interval >=460 millisecond (msec) | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | Heart Rate <50 bpm | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters | QT Interval >=460 millisecond (msec) | 1 Participants |
Primary
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 millimeter of Mercury (mmHg) | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 beats per minute (bpm) | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 millimeter of Mercury (mmHg) | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 beats per minute (bpm) | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 beats per minute (bpm) | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 0 Participants |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 millimeter of Mercury (mmHg) | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 beats per minute (bpm) | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 millimeter of Mercury (mmHg) | 0 Participants |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 0 Participants |
Primary
Part B: Number of Participants Reporting One or More TEAE
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants Reporting One or More TEAE | 15 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants Reporting One or More TEAE | 15 Participants |
Primary
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase \[GOT\]) High, creatine kinase (CK) (creatine phosphokinase \[CPK\]) High, prothrombin time (PT)-international normalized ratio (INR) High.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: White Blood Cell Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Hemoglobin Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 2 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Lymphocyte Count Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Glucose High | 2 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Bilirubin Total High | 0 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: AST (GOT) High | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Gamma-glutamyl Transferase (GGT) High | 2 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: CK (CPK) High | 2 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Corrected Calcium Low | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: PT- INR High | 0 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Triglycerides High | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Triglycerides High | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Triglycerides High | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: White Blood Cell Low | 3 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: AST (GOT) High | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: White Blood Cell Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Corrected Calcium Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Hemoglobin Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Gamma-glutamyl Transferase (GGT) High | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Neutrophil Count Low | 2 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Triglycerides High | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Lymphocyte Count Low | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: CK (CPK) High | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Lymphocyte Count Low | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: PT- INR High | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Glucose High | 2 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 2: Potassium Low | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities | Grade 3: Bilirubin Total High | 1 Participants |
Primary
Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | Heart Rate <50 bpm | 4 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | QT Interval >=460 msec | 5 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | QTcF Interval >=500 msec | 2 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | Heart Rate <50 bpm | 2 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | QT Interval >=460 msec | 4 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters | QTcF Interval >=500 msec | 5 Participants |
Primary
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Here BP is blood pressure.
Time frame: From treatment initiation until 40 days after last dose of study drug (Day 712)
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 mmHg | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 0 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP >110 mmHg | 1 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 bpm | 2 Participants |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 7 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Pulse <50 bpm | 1 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Body Temperature <35.6 degree Celsius | 4 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Systolic BP >180 mmHg | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP >110 mmHg | 0 Participants |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters | Diastolic BP <50 mmHg | 1 Participants |
Secondary
Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28
Time frame: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose
Population: The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 679.7 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 96.34 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 239.0 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 75.02 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 199.0 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 49.487 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 933.0 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 604.3 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 323.4 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 230.4 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 363.8 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 291 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 741.7 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 385.96 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 761.7 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 249.78 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 469.0 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 458.21 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 663.3 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 501.85 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 227.5 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 138.37 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 379.0 hour*nanogram per milliter (h*ng/mL) | Standard Deviation 199.65 |
Secondary
Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28
Time frame: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose
Population: The pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 191.7 nanogram per milliliter (ng/mL) | Standard Deviation 94.405 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 38.10 nanogram per milliliter (ng/mL) | Standard Deviation 21.743 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 23.53 nanogram per milliliter (ng/mL) | Standard Deviation 1.4189 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 198.0 nanogram per milliliter (ng/mL) | Standard Deviation 62.386 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 34.43 nanogram per milliliter (ng/mL) | Standard Deviation 24.962 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 94.40 nanogram per milliliter (ng/mL) | Standard Deviation 115.08 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 216.1 nanogram per milliliter (ng/mL) | Standard Deviation 151.78 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 250.0 nanogram per milliliter (ng/mL) | Standard Deviation 207.56 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 94.70 nanogram per milliliter (ng/mL) | Standard Deviation 114.98 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 1 | 254.0 nanogram per milliliter (ng/mL) | Standard Deviation 330.58 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 28 | 25.56 nanogram per milliliter (ng/mL) | Standard Deviation 16.275 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 | Day 14 | 65.57 nanogram per milliliter (ng/mL) | Standard Deviation 40.84 |
Secondary
Part A: Serum Testosterone Concentrations for TAK-385
Time frame: Up to Day 35
Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 28 | 0.137 ng/mL | Standard Deviation 0.0577 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 35 | 0.130 ng/mL | Standard Deviation 0.0436 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 3 | 0.350 ng/mL | Standard Deviation 0.0917 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 21 | 0.143 ng/mL | Standard Deviation 0.0635 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 2 | 0.603 ng/mL | Standard Deviation 0.1457 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Baseline | 5.440 ng/mL | Standard Deviation 1.6829 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 31 | 0.137 ng/mL | Standard Deviation 0.0416 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 14 | 0.140 ng/mL | Standard Deviation 0.0173 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 7 | 0.283 ng/mL | Standard Deviation 0.0764 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 14 | 0.213 ng/mL | Standard Deviation 0.1102 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 28 | 0.200 ng/mL | Standard Deviation 0.07 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 21 | 0.220 ng/mL | Standard Deviation 0.1044 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 35 | 0.290 ng/mL | Standard Deviation 0.2433 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 2 | 0.977 ng/mL | Standard Deviation 0.5288 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Baseline | 6.505 ng/mL | Standard Deviation 2.6175 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 3 | 0.460 ng/mL | Standard Deviation 0.1852 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 7 | 0.380 ng/mL | Standard Deviation 0.2177 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 31 | 0.217 ng/mL | Standard Deviation 0.1002 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 14 | 0.213 ng/mL | Standard Deviation 0.1012 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Baseline | 6.317 ng/mL | Standard Deviation 1.7503 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 7 | 0.377 ng/mL | Standard Deviation 0.1332 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 2 | 0.777 ng/mL | Standard Deviation 0.2485 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 3 | 0.483 ng/mL | Standard Deviation 0.1762 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 21 | 0.207 ng/mL | Standard Deviation 0.0635 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 28 | 0.190 ng/mL | Standard Deviation 0.0693 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 31 | 0.170 ng/mL | Standard Deviation 0.0436 |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 35 | 0.153 ng/mL | Standard Deviation 0.0321 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 28 | 0.243 ng/mL | Standard Deviation 0.0802 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 7 | 0.337 ng/mL | Standard Deviation 0.0416 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 3 | 0.623 ng/mL | Standard Deviation 0.3232 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 35 | 0.167 ng/mL | Standard Deviation 0.0473 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 31 | 0.210 ng/mL | Standard Deviation 0.0854 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 2 | 1.477 ng/mL | Standard Deviation 1.354 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 21 | 0.207 ng/mL | Standard Deviation 0.0666 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Day 14 | 0.203 ng/mL | Standard Deviation 0.0379 |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part A: Serum Testosterone Concentrations for TAK-385 | Baseline | 7.853 ng/mL | Standard Deviation 1.1885 |
Secondary
Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF)
Time frame: Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)
Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) | -89.77 percent change | Standard Deviation 13.886 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) | -93.91 percent change | Standard Deviation 5.161 |
Secondary
Part B: Plasma Concentration of Unchanged TAK-385
Time frame: Up to Week 49 Day 1
Population: The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 5 Day 1: 2 hours postdose | 20.90 ng/mL | Standard Deviation 19.603 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 9 Day 1 | 4.076 ng/mL | Standard Deviation 2.1577 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 2 Day 1 | 3.972 ng/mL | Standard Deviation 1.7426 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 13 Day 1 | 4.239 ng/mL | Standard Deviation 2.2374 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 1: 2 hours postdose | 72.89 ng/mL | Standard Deviation 123.81 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 17 Day 1 | 4.759 ng/mL | Standard Deviation 2.9601 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 3 Day 1 | 4.123 ng/mL | Standard Deviation 2.2959 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 21 Day 1 | 4.254 ng/mL | Standard Deviation 2.0265 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 4 | 4.683 ng/mL | Standard Deviation 2.7897 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 25 Day 1 | 5.592 ng/mL | Standard Deviation 3.2911 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 5 Day 1 | 4.122 ng/mL | Standard Deviation 1.8301 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 37 Day 1 | 4.924 ng/mL | Standard Deviation 3.7682 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 2 | 6.406 ng/mL | Standard Deviation 6.0223 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 49 Day 1 | 4.683 ng/mL | Standard Deviation 3.1686 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 1 | 0.000 ng/mL | Standard Deviation 0 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 49 Day 1 | 10.08 ng/mL | Standard Deviation 8.1482 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 1 | 0.000 ng/mL | Standard Deviation 0 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 1: 2 hours postdose | 88.58 ng/mL | Standard Deviation 124.65 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 2 | 9.854 ng/mL | Standard Deviation 7.4824 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 1 Day 4 | 7.565 ng/mL | Standard Deviation 5.0412 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 2 Day 1 | 8.146 ng/mL | Standard Deviation 5.337 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 3 Day 1 | 8.618 ng/mL | Standard Deviation 6.8455 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 5 Day 1 | 9.105 ng/mL | Standard Deviation 6.6634 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 5 Day 1: 2 hours postdose | 30.82 ng/mL | Standard Deviation 35.77 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 9 Day 1 | 9.496 ng/mL | Standard Deviation 6.6435 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 13 Day 1 | 9.820 ng/mL | Standard Deviation 7.286 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 17 Day 1 | 9.269 ng/mL | Standard Deviation 6.2961 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 21 Day 1 | 11.08 ng/mL | Standard Deviation 10.873 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 25 Day 1 | 11.95 ng/mL | Standard Deviation 11.792 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Plasma Concentration of Unchanged TAK-385 | Week 37 Day 1 | 11.32 ng/mL | Standard Deviation 10.759 |
Secondary
Part B: Serum Testosterone Concentrations for TAK-385
Time frame: Up to Week 97 Day 1
Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 1 Day 2 | 0.975 ng/mL | Standard Deviation 0.5247 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 21 Day 1 | 0.222 ng/mL | Standard Deviation 0.0844 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 5 Day 1 | 0.213 ng/mL | Standard Deviation 0.0701 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 25 Day 1 | 0.218 ng/mL | Standard Deviation 0.0816 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 2 Day 1 | 0.285 ng/mL | Standard Deviation 0.0741 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 37 Day 1 | 0.229 ng/mL | Standard Deviation 0.1046 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 9 Day 1 | 0.195 ng/mL | Standard Deviation 0.0554 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 49 Day 1 | 0.228 ng/mL | Standard Deviation 0.0922 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 1 Day 4 | 0.384 ng/mL | Standard Deviation 0.0968 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 61 Day 1 | 0.204 ng/mL | Standard Deviation 0.0823 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 13 Day 1 | 0.209 ng/mL | Standard Deviation 0.0746 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 73 Day 1 | 0.218 ng/mL | Standard Deviation 0.0974 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 3 Day 1 | 0.207 ng/mL | Standard Deviation 0.058 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 85 Day 1 | 0.253 ng/mL | Standard Deviation 0.0878 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 17 Day 1 | 0.217 ng/mL | Standard Deviation 0.0757 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 97 Day 1 | 0.283 ng/mL | Standard Deviation 0.1364 |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Baseline | 6.367 ng/mL | Standard Deviation 1.993 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 97 Day 1 | 0.311 ng/mL | Standard Deviation 0.1792 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Baseline | 7.243 ng/mL | Standard Deviation 2.2424 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 1 Day 2 | 0.867 ng/mL | Standard Deviation 0.5835 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 1 Day 4 | 0.463 ng/mL | Standard Deviation 0.2313 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 2 Day 1 | 0.318 ng/mL | Standard Deviation 0.1165 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 3 Day 1 | 0.235 ng/mL | Standard Deviation 0.0925 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 5 Day 1 | 0.190 ng/mL | Standard Deviation 0.067 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 9 Day 1 | 0.191 ng/mL | Standard Deviation 0.0818 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 13 Day 1 | 0.181 ng/mL | Standard Deviation 0.0631 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 17 Day 1 | 0.175 ng/mL | Standard Deviation 0.0548 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 21 Day 1 | 0.179 ng/mL | Standard Deviation 0.0794 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 25 Day 1 | 0.202 ng/mL | Standard Deviation 0.1069 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 37 Day 1 | 0.208 ng/mL | Standard Deviation 0.1177 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 49 Day 1 | 0.196 ng/mL | Standard Deviation 0.0849 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 61 Day 1 | 0.212 ng/mL | Standard Deviation 0.1111 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 73 Day 1 | 0.203 ng/mL | Standard Deviation 0.1206 |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part B: Serum Testosterone Concentrations for TAK-385 | Week 85 Day 1 | 0.259 ng/mL | Standard Deviation 0.1358 |