Trial Outcomes & Findings for Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration (NCT NCT02716987)
NCT ID: NCT02716987
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)
Results posted on
2021-06-14
Participant Flow
Participants took part in the study at 2 investigative sites in the United Kingdom from 21-Mar-2016 to 30-Aug-2016.
Healthy participants in Set A received up to 100 megabecquerel (MBq) of \[18F\]PGM299 for 3 PET scans at baseline, 2, and 26 hours post TAK-831. Set A participants also received a single dose of TAK-831 (100 milligram \[mg\], 200 mg, 250 mg, or 500 mg). Healthy participants in Set B received up 100 MBq of \[18F\]PGM299 for 2 PET scans on Day 1 and 10.
Participant milestones
| Measure |
Set A: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of Positron Emission Tomography (PET) ligand PGM028299 labeled with \[18F\] (\[18F\]PGM299) with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
5
|
2
|
6
|
1
|
|
Overall Study
COMPLETED
|
4
|
2
|
4
|
2
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Set A: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of Positron Emission Tomography (PET) ligand PGM028299 labeled with \[18F\] (\[18F\]PGM299) with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Overall Study
Ligand synthesis failure
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
Baseline characteristics by cohort
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
n=6 Participants
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
n=1 Participants
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Smoking Classification
Never smoked
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Smoking Classification
Ex-smoker
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Alcohol Classification
Never drunk
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Alcohol Classification
Current drinker
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Alcohol Classification
Ex-drinker
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Caffeine Consumption
Caffeine consumption
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Caffeine Consumption
No caffeine consumption
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)Population: The set included all participants who had at least 1 technically adequate PET scan.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
n=6 Participants
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
n=1 Participants
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 1- PET Scan 1
|
1.211 milliliter per cubic centimeter(mL/cm^3)
|
1.247 milliliter per cubic centimeter(mL/cm^3)
|
1.349 milliliter per cubic centimeter(mL/cm^3)
|
1.683 milliliter per cubic centimeter(mL/cm^3)
|
0.658 milliliter per cubic centimeter(mL/cm^3)
|
0.863 milliliter per cubic centimeter(mL/cm^3)
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 1- PET Scan 2
|
0.400 milliliter per cubic centimeter(mL/cm^3)
|
0.126 milliliter per cubic centimeter(mL/cm^3)
|
0.247 milliliter per cubic centimeter(mL/cm^3)
|
0.114 milliliter per cubic centimeter(mL/cm^3)
|
1.109 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported because participant discontinued the study after Baseline PET scan 1.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 1- PET Scan 3
|
1.467 milliliter per cubic centimeter(mL/cm^3)
|
0.543 milliliter per cubic centimeter(mL/cm^3)
|
0.58 milliliter per cubic centimeter(mL/cm^3)
|
1.182 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported because participant discontinued the study after Baseline PET scan 1.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 2- PET Scan 1
|
0.663 milliliter per cubic centimeter(mL/cm^3)
|
1.585 milliliter per cubic centimeter(mL/cm^3)
|
0.743 milliliter per cubic centimeter(mL/cm^3)
|
2.095 milliliter per cubic centimeter(mL/cm^3)
|
0.884 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 2- PET Scan 2
|
0.241 milliliter per cubic centimeter(mL/cm^3)
|
0.217 milliliter per cubic centimeter(mL/cm^3)
|
0.266 milliliter per cubic centimeter(mL/cm^3)
|
0.172 milliliter per cubic centimeter(mL/cm^3)
|
1.130 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 2- PET Scan 3
|
0.809 milliliter per cubic centimeter(mL/cm^3)
|
0.77 milliliter per cubic centimeter(mL/cm^3)
|
0.425 milliliter per cubic centimeter(mL/cm^3)
|
0.553 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 3- PET Scan 1
|
1.397 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.981 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
1.504 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 3- PET Scan 2
|
0.858 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.189 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
1.388 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 3-PET Scan 3
|
1.078 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.802 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 4- PET Scan 1
|
1.297 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.853 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
1.459 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 4- PET Scan 2
|
0.592 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.254 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.979 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 4-PET Scan 3
|
1.055 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.67 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 5- PET Scan 1
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only four participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.976 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
0.895 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 5- PET Scan 2
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only four participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
PET scan 2 was not performed due to ligand synthesis failure.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
1.077 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 5- PET Scan 3
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only four participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
PET scan 3 was not performed due to ligand synthesis failure.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 6- PET Scan 1
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only four participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only five participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
1.036 milliliter per cubic centimeter(mL/cm^3)
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
|
Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan
Participant 6 -PET Scan 2
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only four participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only five participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only two participants were enrolled in this arm.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data is not available because this participant withdrew the study after PET Scan 1.
|
NA milliliter per cubic centimeter(mL/cm^3)
Data was not reported because only one participant was included in this arm.
|
PRIMARY outcome
Timeframe: Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)Population: The set included all participants who had at least 1 technically adequate PET scan.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
n=6 Participants
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
n=1 Participants
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 1- PET Scan 1
|
10.99 ratio
|
7.31 ratio
|
6.71 ratio
|
8.96 ratio
|
3.77 ratio
|
5.49 ratio
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 1- PET Scan 2
|
3.26 ratio
|
-0.28 ratio
|
0.47 ratio
|
-0.20 ratio
|
4.99 ratio
|
NA ratio
Data not reported because participant discontinued the study after Baseline PET scan 1.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 1- PET Scan 3
|
7.89 ratio
|
4.22 ratio
|
4.32 ratio
|
11.19 ratio
|
NA ratio
Data not reported since only PET Scan 1 and 2 were planned to be analysed in Set B.
|
NA ratio
Data not reported because participant discontinued the study after Baseline PET scan 1.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 2- PET Scan 1
|
3.88 ratio
|
8.38 ratio
|
3.53 ratio
|
13.35 ratio
|
13.49 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 2- PET Scan 2
|
1.01 ratio
|
0.16 ratio
|
0.25 ratio
|
0.06 ratio
|
5.89 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 2- PET Scan 3
|
4.39 ratio
|
6.06 ratio
|
2.17 ratio
|
4.59 ratio
|
NA ratio
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 3- PET Scan 1
|
7.22 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
4.80 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
7.13 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 3- PET Scan 2
|
5.13 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
0.01 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
7.46 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 3-PET Scan 3
|
4.53 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
3.53 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 4- PET Scan 1
|
7.37 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
4.84 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
7.48 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 4- PET Scan 2
|
2.72 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
0.37 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
4.35 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 4-PET Scan 3
|
11.13 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
3.38 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 5- PET Scan 1
|
NA ratio
Data was not reported because only four participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
3.69 ratio
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
5.30 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 5- PET Scan 2
|
NA ratio
Data was not reported because only four participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
PET scan 2 was not performed due to ligand synthesis failure.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
6.38 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 5- PET Scan 3
|
NA ratio
Data was not reported because only four participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
PET scan 3 was not performed due to ligand synthesis failure.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data not reported since only PET Scan 1 and 2 were planned to be analyzed in Set B.
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 6- PET Scan 1
|
NA ratio
Data was not reported because only four participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data was not reported because only five participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
8.29 ratio
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
|
Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan
Participant 6- PET Scan 2
|
NA ratio
Data was not reported because only four participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data was not reported because only five participants were enrolled in this arm.
|
NA ratio
Data was not reported because only two participants were enrolled in this arm.
|
NA ratio
Data is not available because this participant withdrew the study after PET Scan 1.
|
NA ratio
Data was not reported because only one participant was included in this arm.
|
PRIMARY outcome
Timeframe: Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)Population: Due to variability in localization of \[18F\]PGM299 in both Cerebellar GM and Frontal Cortex GM, DAO occupancy estimation as a percent difference from baseline and post-TAK-831 dosing PET scans in Cerebellar GM based on VT values could not be made.
DAO occupancy is calculated as percent difference between baseline and postdose \[18F\]PGM299 BPND for each participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Set A: Baseline, 2 and 26 hours post-TAK-831 dosePopulation: The PET target occupancy set included all participants who received study drug (TAK-831) and had a technically adequate baseline PET scan and at least 1 technically adequate post-TAK-831 dose PET scan.
EC50 was obtained from global VT model. The affinity constant relating plasma concentration of TAK-831 to DAO occupancy (EC50) was estimated by fitting the PET and plasma concentration data (VT, Cp). It was calculated as VT= VsBase (EC50/EC50+Cp) + VND, where Vs Base was the group-level (global) volume of distribution of the specific binding in the target region (cerebellar GM) and VND was the volume of distribution of the non-displaceable component (non-specific bound and free radiotracer) of the target region.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=12 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: EC50- Plasma Concentration of TAK-831 That Corresponds to 50 Percent (%) DAO Brain Enzyme Occupancy in Cerebellum
|
12.7 nanogram per milliliter (ng/mL)
Interval 2.3 to 23.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: At 2 and 26 hours post-TAK-831 dosePopulation: The PET target occupancy set included all participants who received study drug (TAK-831) and had a technically adequate baseline PET scan and at least 1 technically adequate post-TAK-831 dose PET scan.
Dose of TAK-831 that corresponds to 50% DAO brain enzyme occupancy in cerebellum at the time of maximum observed plasma concentration (Tmax) of TAK-831 was estimated.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=12 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Dose of TAK-831 That Corresponds to 50% DAO Brain Enzyme Occupancy in Cerebellum
|
100 mg
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Set B: Baseline up to Day 10Population: The analysis set included all participants in Set B who had completed technically evaluable test and re-test PET scans.
CoV was calculated as COV (P)(%) = 100 \* mean/ standard deviation, where P was different participant scanned under baseline condition.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=5 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set B: Coefficient of Variation (CoV) of [18F]PGM299 Binding in Healthy Human Brain
|
30.13 percentage of CoV
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Days 1 and 2 At time 0 (at tracer injection), 60 minutes after tracer injection and 120 minutes after tracer injection for each post TAK-831 dosing PET scan periodPopulation: Pharmacokinetic(PK) set where data at specified time points post-tracer injection was available.PK set included all participants who received study drug(TAK-831)and had at least 1 measurable plasma concentration for TAK-831.Data was reported for Participant 1,2,3 and 4 of each of TAK-831 100,250mg and Participant 1 and 2 of TAK-831 200,500mg arms.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=4 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 1: pre-tracer dose
|
211.250 nanogram per milliliter (ng/mL)
Interval 163.0 to 271.0
|
416.500 nanogram per milliliter (ng/mL)
Interval 201.0 to 632.0
|
273.750 nanogram per milliliter (ng/mL)
Interval 168.0 to 321.0
|
1404.500 nanogram per milliliter (ng/mL)
Interval 889.0 to 1920.0
|
—
|
—
|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 1: 60 minutes post-tracer dose
|
83.375 nanogram per milliliter (ng/mL)
Interval 55.4 to 95.8
|
129.050 nanogram per milliliter (ng/mL)
Interval 78.1 to 180.0
|
122.725 nanogram per milliliter (ng/mL)
Interval 68.9 to 196.0
|
376.500 nanogram per milliliter (ng/mL)
Interval 254.0 to 499.0
|
—
|
—
|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 1: 120 minutes post-tracer dose
|
42.500 nanogram per milliliter (ng/mL)
Interval 24.7 to 48.7
|
82.000 nanogram per milliliter (ng/mL)
Interval 64.0 to 100.0
|
89.925 nanogram per milliliter (ng/mL)
Interval 46.0 to 176.0
|
176.000 nanogram per milliliter (ng/mL)
Interval 130.0 to 222.0
|
—
|
—
|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 2: pre-tracer dose
|
4.028 nanogram per milliliter (ng/mL)
Interval 2.74 to 7.21
|
7.360 nanogram per milliliter (ng/mL)
Interval 5.89 to 8.83
|
11.025 nanogram per milliliter (ng/mL)
Interval 8.17 to 14.2
|
23.400 nanogram per milliliter (ng/mL)
Interval 12.7 to 34.1
|
—
|
—
|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 2: 60 minutes post-tracer dose
|
3.140 nanogram per milliliter (ng/mL)
Interval 1.62 to 5.74
|
5.205 nanogram per milliliter (ng/mL)
Interval 4.41 to 6.0
|
9.658 nanogram per milliliter (ng/mL)
Interval 6.6 to 13.8
|
28.455 nanogram per milliliter (ng/mL)
Interval 9.61 to 47.3
|
—
|
—
|
|
Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods
Day 2: 120 minutes post-tracer dose
|
3.123 nanogram per milliliter (ng/mL)
Interval 1.26 to 5.89
|
5.380 nanogram per milliliter (ng/mL)
Interval 3.82 to 6.94
|
8.665 nanogram per milliliter (ng/mL)
Interval 5.7 to 14.6
|
33.975 nanogram per milliliter (ng/mL)
Interval 8.15 to 59.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Baseline, 24 hours post-TAK-831 dosePopulation: The pharmacodynamic (PD) set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Percent Change From Baseline to Post-TAK-831 Dose in AUEC(0-24)Serine: Area Under the Effect-time Curve From Time 0 to 24 Hours Post-TAK-831 Dose for Dextro-serine (D-serine) and Levo-serine (L-serine)
D-serine
|
8.65 percent change
Standard Deviation 7.209
|
21.90 percent change
Standard Deviation NA
Standard deviation (SD) could not be estimated because only two participants were enrolled in this arm.
|
18.08 percent change
Standard Deviation 8.309
|
8.70 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
|
Set A: Percent Change From Baseline to Post-TAK-831 Dose in AUEC(0-24)Serine: Area Under the Effect-time Curve From Time 0 to 24 Hours Post-TAK-831 Dose for Dextro-serine (D-serine) and Levo-serine (L-serine)
L-serine
|
10.88 percent change
Standard Deviation 5.905
|
2.00 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
-2.46 percent change
Standard Deviation 10.301
|
5.10 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Baseline, 24 hours post-TAK-831 dosePopulation: The PD set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Percent Change From Baseline to Post-TAK-831 Dose in AUEC(0-24)Serine: Area Under the Effect-time Curve From Time 0 to 24 Hours Post-TAK-831 Dose for Ratio of D-serine to Total Serine
|
-1.18 percent change
Standard Deviation 4.748
|
19.75 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
21.30 percent change
Standard Deviation 6.958
|
6.25 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Baseline, 24 hours post-TAK-831 dosePopulation: The PD set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Percent Change in Maximum Drug-induced Effect (Emax,Serine) on Change in Plasma Concentrations of D-serine and L-serine
D-serine
|
9.58 percent change
Standard Deviation 9.769
|
27.05 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
17.46 percent change
Standard Deviation 9.122
|
40.30 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
|
Set A: Percent Change in Maximum Drug-induced Effect (Emax,Serine) on Change in Plasma Concentrations of D-serine and L-serine
L-serine
|
17.40 percent change
Standard Deviation 7.318
|
11.50 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
-2.02 percent change
Standard Deviation 12.917
|
16.10 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Baseline, 24 hours post-TAK-831 dosePopulation: The PD set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Percent Change in Maximum Drug-induced Effect (Emax, D: Total Serine Ratio) on the Ratio of D-serine to Total Serine
|
-1.40 percent change
Standard Deviation 9.515
|
20.95 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
25.38 percent change
Standard Deviation 12.604
|
20.45 percent change
Standard Deviation NA
SD could not be estimated because only two participants were enrolled in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Day -1 At 1, 4 and 12 hours post check-in and Day 1 pre-dose and at multiple time points (up to 24 hours) post-TAK-831 dosePopulation: The PD set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing. PD set where data at specified time points were available.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for D-serine and L-serine
D-serine: Day -1
|
4.955 hours
Interval 1.0 to 12.0
|
1.000 hours
Interval 1.0 to 1.0
|
3.320 hours
Interval 1.0 to 10.6
|
11.900 hours
Interval 11.9 to
Maximum value could not be calculated, because only one participant in this arm.
|
—
|
—
|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for D-serine and L-serine
D-serine: Day 1
|
18.000 hours
Interval 12.0 to 20.0
|
18.000 hours
Interval 12.0 to 24.0
|
15.206 hours
Interval 4.03 to 20.0
|
25.100 hours
Interval 20.0 to 30.2
|
—
|
—
|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for D-serine and L-serine
L-serine: Day -1
|
4.267 hours
Interval 1.0 to 10.8
|
5.750 hours
Interval 1.0 to 10.5
|
6.086 hours
Interval 2.33 to 10.6
|
2.350 hours
Interval 2.35 to
Maximum value could not be calculated, because only one participant in this arm.
|
—
|
—
|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for D-serine and L-serine
L-serine: Day 1
|
13.993 hours
Interval 3.97 to 20.0
|
24.000 hours
Interval 24.0 to 24.0
|
12.026 hours
Interval 4.03 to 20.0
|
30.200 hours
Interval 30.2 to
Maximum value could not be calculated, because only one participant in this arm.
|
—
|
—
|
SECONDARY outcome
Timeframe: Set A: Day -1 At 1, 4 and 12 hours post check-in and Day 1 pre-dose and at multiple time points (up to 24 hours) post-TAK-831 dosePopulation: The PD set for D- and L-serine included all participants in Set A who received study drug (TAK-831) and had at least 1 measurable D- and L-serine plasma measurement both at pre-dose and following TAK-831 dosing. PD set where data at specified time points were available.
Outcome measures
| Measure |
Set A: TAK-831 100 mg
n=4 Participants
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 200 mg
n=2 Participants
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 250 mg
n=5 Participants
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set A: TAK-831 500 mg
n=2 Participants
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 26 hours post-TAK-831 dose.
|
Set B: [18F]PGM299
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for Ratio of D-serine to Total Serine
Day -1
|
6.875 hours
Interval 1.0 to 12.0
|
1.000 hours
Interval 1.0 to
Maximum value could not be calculated, because only one participant in this arm.
|
1.875 hours
Interval 1.0 to 2.5
|
11.100 hours
Interval 10.3 to 11.9
|
—
|
—
|
|
Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for Ratio of D-serine to Total Serine
Day 1
|
26.725 hours
Interval 23.6 to 29.9
|
25.000 hours
Interval 20.0 to 30.0
|
23.750 hours
Interval 8.05 to 30.4
|
30.100 hours
Interval 30.0 to 30.2
|
—
|
—
|
Adverse Events
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 100 mg Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 200 mg Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 250 mg Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 500 mg Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Set A: TAK-831 100 mg Dose to Prior [18F]PGM299 Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Set A: TAK-831 200 mg Dose to Prior [18F]PGM299 Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Set A: TAK-831 250 mg Dose to Prior [18F]PGM299 Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Set A: TAK-831 500 mg Dose to Prior [18F]PGM299 Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SetA:TAK-831 100mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SetA:TAK-831 200mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SetA:TAK-831 250mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SetA:TAK-831 500mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Set B: [18F]PGM299
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Set A: [18F]PGM299 Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 100 mg Dose
n=4 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 100 mg, suspension, orally, once on Day 1.
|
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 200 mg Dose
n=2 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 200 mg, suspension, orally, once on Day 1.
|
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 250 mg Dose
n=5 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 250 mg, suspension, orally, once on Day 1.
|
Set A: [18F]PGM299 Dose 1 to Prior TAK-831 500 mg Dose
n=2 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline; and prior to TAK-831 500 mg, suspension, orally, once on Day 1.
|
Set A: TAK-831 100 mg Dose to Prior [18F]PGM299 Dose 2
n=4 participants at risk
TAK-831 100 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at \[18F\]PGM299 Dose 2 (2 hours post-TAK-831 dose).
|
Set A: TAK-831 200 mg Dose to Prior [18F]PGM299 Dose 2
n=2 participants at risk
TAK-831 200 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F\]PGM299 Dose 2 (2 hours post-TAK-831 dose).
|
Set A: TAK-831 250 mg Dose to Prior [18F]PGM299 Dose 2
n=5 participants at risk
TAK-831 250 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F\]PGM299 Dose 2 (2 hours post-TAK-831 dose).
|
Set A: TAK-831 500 mg Dose to Prior [18F]PGM299 Dose 2
n=2 participants at risk
TAK-831 500 mg, suspension, orally, once on Day 1 and up to 100 MBq of \[18F\]PGM299 with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 18F\]PGM299 Dose 2 (2 hours post-TAK-831 dose).
|
SetA:TAK-831 100mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
n=4 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 100 mg dose up to follow up on Day 15.
|
SetA:TAK-831 200mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
n=2 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 200 mg dose up to follow up on Day 15.
|
SetA:TAK-831 250mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
n=5 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 250 mg dose up to follow up on Day 15.
|
SetA:TAK-831 500mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)
n=2 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at 26 hours post-TAK-831 500 mg dose up to follow up on Day 15.
|
Set B: [18F]PGM299
n=6 participants at risk
\[18F\]PGM299 up to 100 MBq (with a maximal mass up to 12.5 mcg), injection, intravenously, prior to PET imaging on Days 1 and 10.
|
Set A: [18F]PGM299 Baseline
n=1 participants at risk
\[18F\]PGM299 up to 100 MBq with a maximal mass up to 12.5 mcg, injection, intravenously, prior to PET imaging at Baseline only. Participant in this reporting group discontinued from the study and did not receive any TAK-831 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site pain
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
40.0%
2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
40.0%
2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
General disorders
Catheter site bruise
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
25.0%
1/4 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the PI may publish results of the study following the publication of results by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER