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A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

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: NCT03706469
Recruitment Status : Completed
First Posted : October 16, 2018
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy Volunteers
Interventions Drug: TAK-831 T2
Drug: TAK-831 T3
Enrollment 16
Recruitment Details Participants took part in the study at 1 investigative site in the United States from 18 October 2018 to 22 December 2018.
Pre-assignment Details Healthy participants were enrolled and randomized in one of the 4 treatment sequences to receive TAK-831.
Arm/Group Title Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg) Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg) Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg) Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)
Hide Arm/Group Description TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods.
Period Title: Overall Study
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Arm/Group Title Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg) Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg) Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg) Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg) Total
Hide Arm/Group Description TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There was a washout period of at least 7 days between study drug in-take in subsequent treatment periods. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 16
Hide Baseline Analysis Population Description
The safety analysis set included all participants who received at least one dose of the study drug(s).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
40.3  (10.94) 49.0  (8.49) 31.8  (9.22) 30.0  (9.56) 37.8  (11.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
Female
1
  25.0%
4
 100.0%
3
  75.0%
2
  50.0%
10
  62.5%
Male
3
  75.0%
0
   0.0%
1
  25.0%
2
  50.0%
6
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
White
3
  75.0%
4
 100.0%
4
 100.0%
4
 100.0%
15
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
16
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (Kg)
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
80.48  (9.694) 67.55  (6.815) 70.63  (19.643) 76.07  (4.666) 73.68  (11.660)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
175.3  (5.74) 168.3  (6.65) 169.5  (13.48) 169.3  (2.06) 170.6  (7.79)
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 4 participants 4 participants 4 participants 4 participants 16 participants
26.060  (1.6219) 24.090  (4.1222) 24.250  (3.3966) 26.620  (1.9483) 25.255  (2.8796)
1.Primary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
Arm/Group Title TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Hide Arm/Group Description:
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
Overall Number of Participants Analyzed 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter(ng*hr/mL)
714.8
(28.7%)
597.5
(37.0%)
4563
(24.8%)
4665
(41.8%)
8058
(29.0%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of Geometric Mean Ratio (GMR)
Estimated Value 83.60
Confidence Interval (2-Sided) 90%
74.50 to 93.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 102.22
Confidence Interval (2-Sided) 90%
91.10 to 114.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 172.73
Confidence Interval (2-Sided) 90%
152.55 to 195.58
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.
Arm/Group Title TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Hide Arm/Group Description:
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
Overall Number of Participants Analyzed 14 11 16 14 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
761.8
(29.3%)
688.6
(31.0%)
4665
(26.0%)
4558
(41.8%)
7934
(27.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 84.29
Confidence Interval (2-Sided) 90%
73.92 to 96.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 99.61
Confidence Interval (2-Sided) 90%
88.88 to 111.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 172.70
Confidence Interval (2-Sided) 90%
149.07 to 200.09
Estimation Comments [Not Specified]
3.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-831
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.
Arm/Group Title TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Hide Arm/Group Description:
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
Overall Number of Participants Analyzed 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
397.5
(38.8%)
314.6
(40.0%)
1384
(28.9%)
1381
(24.6%)
2394
(37.1%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 79.14
Confidence Interval (2-Sided) 90%
67.36 to 92.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 99.80
Confidence Interval (2-Sided) 90%
84.94 to 117.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.
Method of Estimation Estimation Parameter Percentage of GMR
Estimated Value 173.30
Confidence Interval (2-Sided) 90%
150.05 to 200.16
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description [Not Specified]
Time Frame Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least one dose of the study drug(s).
Arm/Group Title TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Hide Arm/Group Description:
TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence.
TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
Overall Number of Participants Analyzed 16 16 16 16 16
Measure Type: Number
Unit of Measure: percentage of participants
0 13 0 6 0
Time Frame Day 1 post dose up to 14 days after the last dose of study drug ( Up to Day 47).
Adverse Event Reporting Description At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. 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-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Hide Arm/Group Description TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence. TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence. TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence. TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, 2, 3 or 4 as per assigned treatment sequence. TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5.
All-Cause Mortality
TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAK-831 T2 50 mg Fasted TAK-831 T3 50 mg Fasted TAK-831 T2 600 mg Fasted TAK-831 T3 600 mg Fasted TAK-831 T3 600 mg Fed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   2/16 (12.50%)   0/16 (0.00%)   1/16 (6.25%)   0/16 (0.00%) 
Gastrointestinal disorders           
Constipation  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Nervous system disorders           
Headache  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
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
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 ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT03706469    
Other Study ID Numbers: TAK-831-1006
U1111-1217-5483 ( Registry Identifier: WHO )
First Submitted: October 11, 2018
First Posted: October 16, 2018
Results First Submitted: December 2, 2019
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019