Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 948 for:    tablet | Japan

A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348658
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: TAK-536TCH
Enrollment 12
Recruitment Details Participants took part in the study at 1 investigative site in Japan from 29 January 2015 to 11 March 2015.
Pre-assignment Details Healthy adult male participants were enrolled in 1 of 2 treatment sequences in either of the Periods 1 or 2: Sequence A: TAK-536TCH (combination drug of TAK-536 [azilsartan], amlodipine besilate [AML], hydrochlorothiazide [HTZ]) Fasted in Period 1+ TAK-536TCH Fed in period 2; Sequence B: TAK-536TCH Fed in Period 1+ TAK-536TCH Fasted in Period 2.
Arm/Group Title TAK-536TCH Fasted + TAK-536TCH Fed TAK-536TCH Fed + TAK-536TCH Fasted
Hide Arm/Group Description TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2. TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
Period Title: Period 1 (7 Days)
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Washout Period (22 Days)
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Period 2 (7 Days)
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
22.2  (3.54)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 12 participants
12
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 12 participants
12
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 12 participants
171.3  (6.03)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 12 participants
61.18  (5.548)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 12 participants
20.85  (1.499)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Never Smoked 6
Current Smoker 3
Ex-Smoker 3
Alcohol Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Drinks a few Days per Month 7
Had Never Drunk 5
Caffeine Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Caffeine Consumer 1
Caffeine Non-Consumer 11
1.Primary Outcome
Title Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
Hide Description [Not Specified]
Time Frame Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
TAK-536 1912.0  (253.39) 1783.7  (318.16)
M-I 448.3  (143.36) 455.3  (131.68)
M-II 453.5  (109.75) 451.9  (101.18)
HCTZ 119.4  (30.481) 101.6  (14.700)
2.Primary Outcome
Title Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
Hide Description [Not Specified]
Time Frame Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.752  (0.5124) 3.668  (0.6468)
3.Primary Outcome
Title AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Hide Description AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
Time Frame Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
TAK-536 14599.8  (2254.31) 13279.4  (2889.22)
M-I 3215.8  (698.75) 2693.8  (706.41)
M-II 9093.3  (1711.69) 8990.8  (2310.99)
HCTZ 670.8  (75.912) 595.2  (68.915)
4.Primary Outcome
Title AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
Hide Description AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
Time Frame Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
119.370  (27.7395) 125.749  (26.9893)
5.Primary Outcome
Title AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Hide Description AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
TAK-536 14599.8  (2254.31) 13279.4  (2889.22)
M-I 3215.8  (698.75) 2693.8  (706.41)
M-II 9093.3  (1711.69) 8990.8  (2310.99)
HCTZ 641.3  (87.752) 556.4  (70.514)
6.Primary Outcome
Title AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML
Hide Description AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
119.370  (27.7395) 125.749  (26.9893)
7.Primary Outcome
Title AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Hide Description AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time Frame Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
TAK-536 15077.4  (2433.01) 13700.9  (3154.23)
M-I 3271.3  (708.48) 2755.1  (727.37)
M-II 10496.0  (2221.49) 10193.0  (2804.33)
HCTZ 673.5  (87.075) 595.9  (69.847)
8.Primary Outcome
Title AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
Hide Description AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time Frame Day 1: predose and at multiple time points (up to 120 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
132.941  (37.5121) 140.484  (34.4402)
9.Primary Outcome
Title Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
Hide Description Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Time Frame Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: percentage of dose
TAK-536 13.682 13.080
M-I 0.076 0.033
M-II 19.275 19.933
HCTZ 73.742 74.042
10.Primary Outcome
Title Urinary Excretion Ratio of AML
Hide Description Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Time Frame Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: percentage of dose
6.843 7.328
11.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
1 1
12.Secondary Outcome
Title Number of Participants With TEAEs Related to Vital Signs
Hide Description [Not Specified]
Time Frame Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
0 0
13.Secondary Outcome
Title Number of Participants With TEAEs Related to Body Weight
Hide Description [Not Specified]
Time Frame Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
0 0
14.Secondary Outcome
Title Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
Hide Description [Not Specified]
Time Frame Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
1 0
15.Secondary Outcome
Title Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
Hide Description Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.
Time Frame Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description:
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title TAK-536TCH Fasted TAK-536TCH Fed
Hide Arm/Group Description TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2. TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
All-Cause Mortality
TAK-536TCH Fasted TAK-536TCH Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAK-536TCH Fasted TAK-536TCH Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAK-536TCH Fasted TAK-536TCH Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   1/12 (8.33%) 
Gastrointestinal disorders     
Faeces soft  1  0/12 (0.00%)  1/12 (8.33%) 
Investigations     
Blood creatine phosphokinase increased  1  1/12 (8.33%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02348658     History of Changes
Other Study ID Numbers: TAK-536TCH/CPH-004
U1111-1165-5595 ( Registry Identifier: WHO )
JapicCTI-152777 ( Registry Identifier: JapicCTI )
First Submitted: January 15, 2015
First Posted: January 28, 2015
Results First Submitted: March 24, 2016
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016