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Trial record 71 of 1121 for:    tablet | Japan
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A Bioequivalence Study of TAK-536 Pediatric Formulation

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ClinicalTrials.gov Identifier: NCT02401464
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : July 6, 2016
Last Update Posted : July 6, 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 Japanese Healthy Adult Males
Interventions Drug: TAK-536 Tablet
Drug: TAK-536 Dry Syrup Formulation
Drug: TAK-536 Ganule Formulation
Enrollment 52
Recruitment Details Participants took part in the study at 1 investigative site in Japan from 25 March 2015 to 26 May 2015.
Pre-assignment Details Healthy participants were enrolled in 1 of 2 treatment sequences: Sequence a (dry syrup): TAK-536 dry syrup followed by TAK-536 tablet; Sequence b (dry syrup): TAK-536 tablet followed by TAK-536 dry syrup; Sequence a (granules): TAK-536 granules followed by TAK-536 tablet; Sequence b (granules): TAK-536 tablet followed by TAK-536 granules.
Arm/Group Title Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup Granule Cohort: TAK-536 Granules + TAK-536 Tablet Granule Cohort: TAK-536 Tablet + TAK-536 Granules
Hide Arm/Group Description Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
Period Title: Intervention Period 1 (6 Days)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Period Title: Washout Period (At Least 6 Days)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Period Title: Intervention Period 2 (6 Days)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Arm/Group Title Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup Granule Cohort: TAK-536 Granules + TAK-536 Tablet Granule Cohort: TAK-536 Tablet + TAK-536 Granules Total
Hide Arm/Group Description Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days). Total of all reporting groups
Overall Number of Baseline Participants 13 13 13 13 52
Hide Baseline Analysis Population Description
The pharmacokinetic 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 pharmacokinetics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 13 participants 13 participants 52 participants
25.3  (2.21) 25.9  (4.11) 26.6  (4.07) 27.4  (5.71) 26.308  (4.16)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 13 participants 13 participants 13 participants 13 participants 52 participants
13 13 13 13 52
Smoking classification  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 13 participants 13 participants 13 participants 13 participants 52 participants
Never smoked 7 9 7 8 31
Current smoker 0 0 1 1 2
Ex-smoker 6 4 5 4 19
Alcohol classification  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 13 participants 13 participants 13 participants 13 participants 52 participants
Drank a few days per week 1 2 2 0 5
Drank a few days per month 1 3 3 3 10
Never drank 11 8 8 10 37
Caffeine Classification  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 13 participants 13 participants 13 participants 13 participants 52 participants
Had caffeine consumption 2 3 6 5 16
Had no caffeine consumption 11 10 7 8 36
1.Primary Outcome
Title AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic 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 pharmacokinetics.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
7065.6  (1317.91) 7341.2  (1493.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation, Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
Comments Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.
Method of Estimation Estimation Parameter Least Squares (LS) mean difference (ln)
Estimated Value 0.963
Confidence Interval (2-Sided) 90%
0.927 to 1.001
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic 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 pharmacokinetics.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
886.1  (133.76) 976.7  (140.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation, Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation
Comments Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.
Method of Estimation Estimation Parameter LS mean difference (ln)
Estimated Value 0.906
Confidence Interval (2-Sided) 90%
0.880 to 0.933
Estimation Comments [Not Specified]
3.Primary Outcome
Title AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic 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 pharmacokinetics.
Arm/Group Title Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
7749.8  (1188.80) 7893.2  (1336.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Granule Cohort: TAK-536 10 mg Pediatric Formulation, Granule Cohort: TAK-536 10 mg Commercial Formulation
Comments Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.
Method of Estimation Estimation Parameter LS mean difference (ln)
Estimated Value 0.985
Confidence Interval (2-Sided) 90%
0.958 to 1.011
Estimation Comments [Not Specified]
4.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort
Hide Description [Not Specified]
Time Frame Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic 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 pharmacokinetics.
Arm/Group Title Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
943.2  (106.76) 973.7  (178.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Granule Cohort: TAK-536 10 mg Pediatric Formulation, Granule Cohort: TAK-536 10 mg Commercial Formulation
Comments Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.
Method of Estimation Estimation Parameter LS mean difference (ln)
Estimated Value 0.979
Confidence Interval (2-Sided) 90%
0.938 to 1.022
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug at least once.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
5 5 0 3
6.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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug at least once.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
0 1 0 0
7.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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug at least once.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
0 0 0 0
8.Secondary Outcome
Title Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Hide Description [Not Specified]
Time Frame Baseline up to Day 6 of Intervention Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug at least once.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
0 0 0 0
9.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 Day 6 of Intervention Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received the study drug at least once.
Arm/Group Title Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description:
Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
4 5 0 2
Time Frame Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Baseline) and continued until the follow-up examination in Period 2 (Day 6 of Intervention 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 Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Hide Arm/Group Description Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days). Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days). Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days). Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
All-Cause Mortality
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%)   0/26 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation Granule Cohort: TAK-536 10 mg Pediatric Formulation Granule Cohort: TAK-536 10 mg Commercial Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/26 (19.23%)   5/26 (19.23%)   0/26 (0.00%)   3/26 (11.54%) 
Investigations         
Alanine aminotransferase increased † 1  1/26 (3.85%)  2/26 (7.69%)  0/26 (0.00%)  0/26 (0.00%) 
Aspartate aminotransferase increased † 1  1/26 (3.85%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Protein urine present † 1  2/26 (7.69%)  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%) 
Blood pressure decreased † 1  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Blood triglycerides increased † 1  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Blood urine present † 1  0/26 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%) 
Blood creatine phosphokinase increased † 1  0/26 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
Nervous system disorders         
Headache † 1  1/26 (3.85%)  0/26 (0.00%)  0/26 (0.00%)  1/26 (3.85%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
[Not Specified]
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.
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 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: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02401464    
Other Study ID Numbers: TAK-536/CPH-101
U1111-1168-3113 ( Registry Identifier: WHO )
JapicCTI-152853 ( Registry Identifier: JapicCTI )
First Submitted: March 24, 2015
First Posted: March 27, 2015
Results First Submitted: May 25, 2016
Results First Posted: July 6, 2016
Last Update Posted: July 6, 2016