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Trial record 93 of 913 for:    tablet | Japan

A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation

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: NCT03042299
Recruitment Status : Completed
First Posted : February 3, 2017
Results First Posted : October 8, 2018
Last Update Posted : November 14, 2018
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 Japanese Healthy Adult Male Participants
Intervention Drug: TAK-536
Enrollment 14
Recruitment Details Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.
Pre-assignment Details Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive TAK-536 10 milligram (mg) granules (pediatric formulation) or TAK-536 10 mg tablet (commercial formulation).
Arm/Group Title TAK-536 Granules + TAK-536 Tablet TAK-536 Tablet + TAK-536 Granules
Hide Arm/Group Description TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
Period Title: Intervention Period 1 (6 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Washout Period (at Least 6 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Intervention Period 2 (6 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title TAK-536 Granules + TAK-536 Tablet TAK-536 Tablet + TAK-536 Granules Total
Hide Arm/Group Description TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
The safety analysis set included all participants who received the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
21.3  (0.95) 21.3  (1.38) 21.3  (1.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
7
 100.0%
14
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 7 participants 7 participants 14 participants
7
 100.0%
7
 100.0%
14
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 7 participants 7 participants 14 participants
167.7  (3.64) 171.3  (4.42) 169.5  (4.31)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 7 participants 7 participants 14 participants
59.97  (5.586) 60.49  (6.838) 60.23  (6.005)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 7 participants 7 participants 14 participants
21.33  (2.072) 20.61  (2.143) 20.97  (2.060)
Smoking classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Never smoked Number Analyzed 7 participants 7 participants 14 participants
5
  71.4%
4
  57.1%
9
  64.3%
Current smoker Number Analyzed 7 participants 7 participants 14 participants
1
  14.3%
3
  42.9%
4
  28.6%
Ex-smoker Number Analyzed 7 participants 7 participants 14 participants
1
  14.3%
0
   0.0%
1
   7.1%
Alcohol classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Drank a few times per week Number Analyzed 7 participants 7 participants 14 participants
1
  14.3%
2
  28.6%
3
  21.4%
Drank a few times per month Number Analyzed 7 participants 7 participants 14 participants
4
  57.1%
3
  42.9%
7
  50.0%
Never drank Number Analyzed 7 participants 7 participants 14 participants
2
  28.6%
2
  28.6%
4
  28.6%
Caffeine classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Had caffeine consumption Number Analyzed 7 participants 7 participants 14 participants
1
  14.3%
2
  28.6%
3
  21.4%
Had no caffeine consumption Number Analyzed 7 participants 7 participants 14 participants
6
  85.7%
5
  71.4%
11
  78.6%
1.Primary Outcome
Title AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
6053.7  (1119.60) 6479.6  (1008.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-536 10 mg Granules (Pediatric Formulation), TAK-536 10 mg Tablet (Commercial Formulation)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.
Method of Estimation Estimation Parameter Point estimate
Estimated Value -0.0731
Confidence Interval (2-Sided) 90%
-0.1088 to -0.0373
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
803.3  (113.63) 878.1  (117.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-536 10 mg Granules (Pediatric Formulation), TAK-536 10 mg Tablet (Commercial Formulation)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The difference in the LS means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.
Method of Estimation Estimation Parameter Point estimate
Estimated Value -0.0909
Confidence Interval (2-Sided) 90%
-0.1573 to -0.0244
Estimation Comments [Not Specified]
3.Secondary Outcome
Title AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
6187.4  (1167.72) 6627.4  (1061.66)
4.Secondary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: hours
1.89  (0.738) 2.43  (0.958)
5.Secondary Outcome
Title MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: hours
9.781  (1.4010) 10.11  (1.1873)
6.Secondary Outcome
Title Terminal Disposition Phase Rate Constant (λz) for TAK-536
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: liter per hour (L/h)
0.06866  (0.0046324) 0.06862  (0.0077457)
7.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame Baseline up to Day 6 of Intervention Period 2 (Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With TEAEs Related to Vital Signs
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2 (Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received the study drug.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With TEAEs Related to Body Weight
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2 (Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received the study drug.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With TEAEs Related to Electrocardiograms (ECGs)
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2 (Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received the study drug.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With TEAEs Related to Clinical Laboratory Tests
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2 (Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all the participants who received the study drug.
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description:
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame TEAEs were assessed after the first dose of study drug until the follow up examination on Day 6 in Intervention Period 2 (Day 18)
Adverse Event Reporting Description At each visit the investigator or sub-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 or sub-investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Hide Arm/Group Description TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2. TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
All-Cause Mortality
TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TAK-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (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-536 10 mg Granules (Pediatric Formulation) TAK-536 10 mg Tablet (Commercial Formulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
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.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03042299     History of Changes
Other Study ID Numbers: Azilsartan-1004
U1111-1190-0845 ( Registry Identifier: WHO )
JapicCTI-173503 ( Registry Identifier: JapicCTI )
First Submitted: February 1, 2017
First Posted: February 3, 2017
Results First Submitted: February 23, 2018
Results First Posted: October 8, 2018
Last Update Posted: November 14, 2018