Who is sponsoring NCT02141659?

NCT02141659 is sponsored by Takeda.

What drugs are being tested in NCT02141659?

Interventions in NCT02141659: TAK-385.

What condition does NCT02141659 study?

NCT02141659 studies Hormone Treatment-naïve Participants With Prostate Cancer.

Is NCT02141659 still recruiting?

NCT02141659 is currently completed. Last updated 19 November 2018.

Are results published for NCT02141659?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-19 · How we verify

NCT02141659

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer

Completed Phase 1 Results posted Last updated 19 November 2018

What this trial tests

Phase 1 trial testing TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer in 43 participants. Completed in 20 April 2017.

Timeline

1 May 2014

Primary endpoint
20 April 2017

20 April 2017

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 May 2014
Primary completion	20 April 2017
Estimated completion	20 April 2017
Sites	6 locations across Japan

Drugs / interventions tested

TAK-385 — full drug profile →

Conditions studied

Hormone Treatment-naïve Participants With Prostate Cancer — all drugs for Hormone Treatment-naïve Participants With Prostate Cancer →

Sponsor

Takeda — full company profile →

Who can join

20 and older, male only, with Hormone Treatment-naïve Participants With Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Number of Participants With Dose-limiting Toxicities (DLTs) Primary · 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.

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) Primary · From treatment initiation until 40 days after last dose of study drug (Day 68)

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	3
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	3
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	2

Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities Primary · 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.

Grade 2: White Blood Cell Low

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	1

Grade 2: Neutrophil Count Low

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	1

Grade 2: Lymphocyte Count Low

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Grade 2: Potassium Low

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	1
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters Primary · From treatment initiation until 40 days after last dose of study drug (Day 68)

Body Temperature <35.6 degree Celsius

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Systolic BP >180 millimeter of Mercury (mmHg)

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Diastolic BP <50 mmHg

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Pulse <50 beats per minute (bpm)

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters Primary · From treatment initiation until 40 days after last dose of study drug (Day 68)

Heart Rate <50 bpm

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0

QT Interval >=460 millisecond (msec)

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	1

Part B: Number of Participants Reporting One or More TEAE Primary · From treatment initiation until 40 days after last dose of study drug (Day 712)

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	15
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	15

Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities Primary · 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\

Grade 2: White Blood Cell Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	3

Grade 3: White Blood Cell Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0

Grade 3: Hemoglobin Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0

Grade 2: Neutrophil Count Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	2
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2

Grade 2: Lymphocyte Count Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1

Grade 3: Lymphocyte Count Low

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0

Grade 2: Glucose High

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	2
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2

Grade 3: Bilirubin Total High

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1

Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters Primary · From treatment initiation until 40 days after last dose of study drug (Day 712)

Here "BP" is blood pressure.

Body Temperature <35.6 degree Celsius

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	7
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	4

Systolic BP >180 mmHg

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0

Diastolic BP >110 mmHg

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	1
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0

Diastolic BP <50 mmHg

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1

Pulse <50 bpm

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	2
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	1

Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters Primary · From treatment initiation until 40 days after last dose of study drug (Day 712)

Heart Rate <50 bpm

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	4
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	2

QT Interval >=460 msec

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	5
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	4

QTcF Interval >=500 msec

Group	Value	95% CI
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg	2
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg	5

Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 Secondary · 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

Day 1

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	191.7	± 94.405
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	198.0	± 62.386
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	250.0	± 207.56
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	254.0	± 330.58

Day 14

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	23.53	± 1.4189
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	94.40	± 115.08
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	216.1	± 151.78
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	65.57	± 40.840

Day 28

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	38.10	± 21.743
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	34.43	± 24.962
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	94.70	± 114.98
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	25.56	± 16.275

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 Secondary · 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

Day 1

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	679.7	± 96.340
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	933.0	± 604.30
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	761.7	± 249.78
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	663.3	± 501.85

Day 14

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	199.0	± 49.487
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	363.8	± 291.00
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	741.7	± 385.96
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	379.0	± 199.65

Day 28

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	239.0	± 75.020
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	323.4	± 230.40
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	469.0	± 458.21
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	227.5	± 138.37

Part A: Serum Testosterone Concentrations for TAK-385 Secondary · Up to Day 35

Baseline

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	5.440	± 1.6829
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	6.505	± 2.6175
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	6.317	± 1.7503
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	7.853	± 1.1885

Day 2

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.603	± 0.1457
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.977	± 0.5288
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.777	± 0.2485
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	1.477	± 1.3540

Day 3

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.350	± 0.0917
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.460	± 0.1852
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.483	± 0.1762
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.623	± 0.3232

Day 7

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.283	± 0.0764
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.380	± 0.2177
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.377	± 0.1332
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.337	± 0.0416

Day 14

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.140	± 0.0173
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.213	± 0.1102
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.213	± 0.1012
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.203	± 0.0379

Day 21

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.143	± 0.0635
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.220	± 0.1044
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.207	± 0.0635
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.207	± 0.0666

Day 28

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.137	± 0.0577
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.200	± 0.0700
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.190	± 0.0693
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.243	± 0.0802

Day 31

Group	Value	95% CI
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg	0.137	± 0.0416
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg	0.217	± 0.1002
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg	0.170	± 0.0436
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg	0.210	± 0.0854

Adverse events — posted to ClinicalTrials.gov

Time frame: From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg

Serious: 0/3 (0%)

Deaths: 0/3

Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg

Serious: 0/4 (0%)

Deaths: 0/4

Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg

Serious: 0/3 (0%)

Deaths: 0/3

Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg

Serious: 0/3 (0%)

Deaths: 0/3

Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg

Serious: 3/15 (20%)

Deaths: 0/15

Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg

Serious: 3/15 (20%)

Deaths: 0/15

Serious adverse events (9 terms)

Reaction	System	Part A Cohort 1: TAK-385 3…	Part A Cohort 2: TAK-385 3…	Part A Cohort 3: TAK-385 3…	Part A Cohort 4: TAK-385 3…	Part B Cohort 1: TAK-385 3…	Part B Cohort 2: TAK-385 3…
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—	—
Appendicitis perforated	Infections and infestations	—	—	—	—	—	—
Postoperative wound infection	Infections and infestations	—	—	—	—	—	—
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—	—	—
Device loosening	Product Issues	—	—	—	—	—	—
Hydronephrosis	Renal and urinary disorders	—	—	—	—	—	—

Other adverse events (125 terms — click to expand)

Reaction	System	Part A Cohort 1: TAK-385 3…	Part A Cohort 2: TAK-385 3…	Part A Cohort 3: TAK-385 3…	Part A Cohort 4: TAK-385 3…	Part B Cohort 1: TAK-385 3…	Part B Cohort 2: TAK-385 3…
Hot flush	Vascular disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—
Blood cholesterol increased	Investigations	—	—	—	—	—	—
Liver function test increased	Investigations	—	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—	—
Gynaecomastia	Reproductive system and breast disorders	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Drug eruption	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—	—	—
Bundle branch block left	Cardiac disorders	—	—	—	—	—	—
Bundle branch block right	Cardiac disorders	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—
Dermatophytosis of nail	Infections and infestations	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—
Tinea manuum	Infections and infestations	—	—	—	—	—	—
Astigmatism	Eye disorders	—	—	—	—	—	—

Most-reported serious reactions: Gastrointestinal haemorrhage, Inguinal hernia, Jaundice cholestatic, Appendicitis perforated, Postoperative wound infection, Oesophageal carcinoma, Cerebral infarction, Device loosening.

Data from ClinicalTrials.gov NCT02141659 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.
Suzuki H, Uemura H, Mizokami A, Hayashi N, et al · · 2019 · cited 29× · PMID 31429205 · DOI 10.1002/cam4.2442

Verify or expand the search:

Other trials of TAK-385

Trials testing the same drug.

NCT03931915 — Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis · Phase 3 · completed

Other Takeda trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02141659 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 19 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02141659.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02141659

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of TAK-385

Other Takeda trials

Verify against primary sources