A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet formulation.
The study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:
-
T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed
-
T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
-
T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
-
T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed
All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment period.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug for a follow-up assessment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg) 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 will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
Drug: TAK-831 T2
TAK-831 T2 Tablets.
Drug: TAK-831 T3
TAK-831 T3 Tablets.
|
Experimental: Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg) 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 will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
Drug: TAK-831 T2
TAK-831 T2 Tablets.
Drug: TAK-831 T3
TAK-831 T3 Tablets.
|
Experimental: Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg) 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 will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
Drug: TAK-831 T2
TAK-831 T2 Tablets.
Drug: TAK-831 T3
TAK-831 T3 Tablets.
|
Experimental: Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg) 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 will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
Drug: TAK-831 T2
TAK-831 T2 Tablets.
Drug: TAK-831 T3
TAK-831 T3 Tablets.
|
Outcome Measures
Primary Outcome Measures
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 [Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose]
- AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 [Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose]
- Cmax: Maximum Observed Plasma Concentration for TAK-831 [Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose]
Secondary Outcome Measures
- Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram per square meter (kg/m^2), at Screening.
Exclusion Criteria:
-
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
-
Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
-
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
-
Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
-
Donation of blood or significant blood loss within 56 days prior to the first dosing.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Neurocrine Biosciences
- Takeda
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- TAK-831-1006
- U1111-1217-5483
Study Results
Participant Flow
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 Detail | 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) |
---|---|---|---|---|
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 |
Baseline Characteristics
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 |
---|---|---|---|---|---|
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 Participants | 4 | 4 | 4 | 4 | 16 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
40.3
(10.94)
|
49.0
(8.49)
|
31.8
(9.22)
|
30.0
(9.56)
|
37.8
(11.60)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
1
25%
|
4
100%
|
3
75%
|
2
50%
|
10
62.5%
|
Male |
3
75%
|
0
0%
|
1
25%
|
2
50%
|
6
37.5%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
4
100%
|
4
100%
|
4
100%
|
4
100%
|
16
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
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%
|
Black or African American |
1
25%
|
0
0%
|
0
0%
|
0
0%
|
1
6.3%
|
White |
3
75%
|
4
100%
|
4
100%
|
4
100%
|
15
93.8%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||||
United States |
4
100%
|
4
100%
|
4
100%
|
4
100%
|
16
100%
|
Weight (kilogram (Kg)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kilogram (Kg)] |
80.48
(9.694)
|
67.55
(6.815)
|
70.63
(19.643)
|
76.07
(4.666)
|
73.68
(11.660)
|
Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [centimeter (cm)] |
175.3
(5.74)
|
168.3
(6.65)
|
169.5
(13.48)
|
169.3
(2.06)
|
170.6
(7.79)
|
Body mass index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
26.060
(1.6219)
|
24.090
(4.1222)
|
24.250
(3.3966)
|
26.620
(1.9483)
|
25.255
(2.8796)
|
Outcome Measures
Title | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 |
---|---|
Description | |
Time Frame | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
Outcome Measure Data
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 |
---|---|---|---|---|---|
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. |
Measure Participants | 16 | 16 | 16 | 16 | 16 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter(ng*hr/mL)] |
714.8
(28.7)
|
597.5
(37.0)
|
4563
(24.8)
|
4665
(41.8)
|
8058
(29.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
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 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 102.22 | |
Confidence Interval |
(2-Sided) 90% 91.10 to 114.70 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 172.73 | |
Confidence Interval |
(2-Sided) 90% 152.55 to 195.58 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 |
---|---|
Description | |
Time Frame | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
Outcome Measure Data
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 |
---|---|---|---|---|---|
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. |
Measure Participants | 14 | 11 | 16 | 14 | 15 |
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL] |
761.8
(29.3)
|
688.6
(31.0)
|
4665
(26.0)
|
4558
(41.8)
|
7934
(27.3)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 84.29 | |
Confidence Interval |
(2-Sided) 90% 73.92 to 96.11 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 99.61 | |
Confidence Interval |
(2-Sided) 90% 88.88 to 111.63 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 172.70 | |
Confidence Interval |
(2-Sided) 90% 149.07 to 200.09 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Cmax: Maximum Observed Plasma Concentration for TAK-831 |
---|---|
Description | |
Time Frame | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
Outcome Measure Data
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 |
---|---|---|---|---|---|
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. |
Measure Participants | 16 | 16 | 16 | 16 | 16 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)] |
397.5
(38.8)
|
314.6
(40.0)
|
1384
(28.9)
|
1381
(24.6)
|
2394
(37.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 50 mg Fasted, TAK-831 T3 50 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 79.14 | |
Confidence Interval |
(2-Sided) 90% 67.36 to 92.99 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T2 600 mg Fasted, TAK-831 T3 600 mg Fasted |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 99.80 | |
Confidence Interval |
(2-Sided) 90% 84.94 to 117.27 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | TAK-831 T3 600 mg Fasted, TAK-831 T3 600 mg Fed |
---|---|---|
Comments | ||
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%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Percentage of GMR |
Estimated Value | 173.30 | |
Confidence Interval |
(2-Sided) 90% 150.05 to 200.16 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
---|---|
Description | |
Time Frame | Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47) |
Outcome Measure Data
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 |
---|---|---|---|---|---|
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. |
Measure Participants | 16 | 16 | 16 | 16 | 16 |
Number [percentage of participants] |
0
0%
|
13
325%
|
0
0%
|
6
150%
|
0
0%
|
Adverse Events
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 | |||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | |||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | |||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 2/16 (12.5%) | 0/16 (0%) | 1/16 (6.3%) | 0/16 (0%) | |||||
Gastrointestinal disorders | ||||||||||
Constipation | 0/16 (0%) | 1/16 (6.3%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | |||||
Nervous system disorders | ||||||||||
Headache | 0/16 (0%) | 1/16 (6.3%) | 0/16 (0%) | 1/16 (6.3%) | 0/16 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Generally, the PI may publish results of the study following the publication of results by the Sponsor.
Results Point of Contact
Name/Title | Neurocrine Medical Information |
---|---|
Organization | Neurocrine Biosciences |
Phone | 877-641-3461 |
medinfo@neurocrine.com |
- TAK-831-1006
- U1111-1217-5483