Trial Outcomes & Findings for A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants (NCT NCT03500224)
NCT ID: NCT03500224
Last Updated: 2019-07-29
Results Overview
COMPLETED
PHASE1
6 participants
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
2019-07-29
Participant Flow
Participants took part in the study at 1 investigative site in the Netherlands from 30 April 2018 to 01 June 2018.
Healthy participants were enrolled to receive a single 60-minute intravenous infusion of 0.5 milligram (mg) TAK-954 containing a microtracer of \[14C\]-TAK-954.
Participant milestones
| Measure |
[14C]-TAK-954 0.5 mg
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
[14C]-TAK-954 0.5 mg
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
Baseline characteristics by cohort
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=5 Participants
|
|
Weight
|
76.37 kilogram (kg)
STANDARD_DEVIATION 8.694 • n=5 Participants
|
|
Height
|
177.2 centimeter (cm)
STANDARD_DEVIATION 7.78 • n=5 Participants
|
|
Body mass index
|
24.2 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cumulative Percentage of Administered Radioactivity Recovered in Urine
0 to 264 hours
|
55.4 percentage of radioactive dose
Standard Deviation 3.2
|
|
Cumulative Percentage of Administered Radioactivity Recovered in Urine
0 to 312 hours
|
56.8 percentage of radioactive dose
Standard Deviation 3.2
|
|
Cumulative Percentage of Administered Radioactivity Recovered in Urine
0 to 336 hours
|
55.1 percentage of radioactive dose
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cumulative Percentage of Administered Radioactivity Recovered in Feces
0 to 264 hours
|
28.8 percentage of radioactive dose
Standard Deviation 2.5
|
|
Cumulative Percentage of Administered Radioactivity Recovered in Feces
0 to 312 hours
|
30.3 percentage of radioactive dose
Standard Deviation 2.5
|
|
Cumulative Percentage of Administered Radioactivity Recovered in Feces
0 to 336 hours
|
30.0 percentage of radioactive dose
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cumulative Percentage of Radioactivity in Urine and Feces Combined
0 to 312 hours
|
87.0 percentage of radioactive dose
Standard Deviation 4.6
|
|
Cumulative Percentage of Radioactivity in Urine and Feces Combined
0 to 264 hours
|
84.1 percentage of radioactive dose
Standard Deviation 5.3
|
|
Cumulative Percentage of Radioactivity in Urine and Feces Combined
0 to 336 hours
|
85.1 percentage of radioactive dose
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M4, M5, and M16
|
5.0 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M17
|
1.6 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M9
|
0.6 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M1
|
3.0 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M3
|
13.6 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M14
|
4.3 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M7
|
0.5 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
M10
|
1.0 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
TAK-954
|
58.0 percentage of dose
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M1
|
3.0 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M3
|
4.8 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M14
|
4.3 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M5, M4, and M16
|
1.6 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M17
|
0.8 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M9
|
0.6 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
M10
|
0.5 Percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
TAK-954
|
44.3 Percentage of dose
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
M3
|
8.8 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
M5, M4, and M16
|
3.4 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
M17
|
0.8 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
M7
|
0.5 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
M10
|
0.5 percentage of dose
|
|
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
TAK-954
|
13.7 percentage of dose
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Data is reported for TAK-954. Data for metabolites are not reported because none exceeded greater than (\>) 6% of the total plasma radioactivity.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
|
74.28 percentage of total radioactivity
Standard Deviation 8.18
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cumulative Percentage of Dose Excreted in Urine for TAK-954
0 to 336 hours
|
27.35 percentage of dose
Standard Deviation 0.35
|
|
Cumulative Percentage of Dose Excreted in Urine for TAK-954
0 to 264 hours
|
31.33 percentage of dose
Standard Deviation 3.29
|
|
Cumulative Percentage of Dose Excreted in Urine for TAK-954
0 to 312 hours
|
29.73 percentage of dose
Standard Deviation 4.14
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Single sampling method used across participants, therefore there was no measure of dispersion.
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cumulative Percentage of Dose Excreted in Feces for TAK-954
|
13.7 percentage of dose
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 1.5 hour
|
2.88 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.523
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 2 hour
|
2.40 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.418
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 3 hour
|
2.05 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.349
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 312 hour
|
NA nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation NA
Data were not reported because none of the values were above LLOQ.
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 336 hour
|
NA nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation NA
Data were not reported because none of the values were above LLOQ.
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 0.00 minute
|
NA nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation NA
Data were not reported because none of the values were above lower limit of quantification (LLOQ).
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 0.50 minute
|
5.15 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.908
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 1 hour
|
5.87 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 1.26
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 4 hour
|
2.09 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.407
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 6 hour
|
1.79 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.385
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 12 hour
|
1.40 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.217
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 24 hour
|
0.923 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.114
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 36 hour
|
0.583 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0874
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 72 hour
|
0.232 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0530
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 96 hour
|
0.140 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0420
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 120 hour
|
0.0953 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0292
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 144 hour
|
0.0695 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0211
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 168 hour
|
0.0449 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0363
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 192 hour
|
0.0352 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0332
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 216 hour
|
0.0268 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0301
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 240 hour
|
0.0246 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0273
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 264 hour
|
0.00940 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0230
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Whole Blood: 288 hour
|
NA nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation NA
Data were not reported because none of the values were above LLOQ.
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 0.00 minute
|
NA nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation NA
Data were not reported because none of the values were above LLOQ.
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 0.50 minute
|
5.74 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 1.72
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 1 hour
|
6.29 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 1.22
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 1.5 hour
|
3.06 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.528
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 2 hour
|
2.59 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.566
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 3 hour
|
2.27 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.495
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 4 hour
|
2.17 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.437
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 6 hour
|
1.77 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.433
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 12 hour
|
1.34 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.209
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 24 hour
|
0.983 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.104
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 36 hour
|
0.601 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0567
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 48 hour
|
0.443 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0478
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 72 hour
|
0.271 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0502
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 96 hour
|
0.169 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0368
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 120 hour
|
0.123 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0378
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 144 hour
|
0.0907 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0276
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 168 hour
|
0.0689 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0264
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 192 hour
|
0.0552 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0163
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 216 hour
|
0.0480 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0131
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 240 hour
|
0.0486 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0175
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 264 hour
|
0.0407 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0114
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 288 hour
|
0.0429 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.0166
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 312 hour
|
0.0413 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.00559
|
|
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Plasma: 336 hour
|
0.0349 nanogram equivalent/milliliter(ng eq/mL)
Standard Deviation 0.00700
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Plasma
|
6.28 ng eq/mL
Interval 4.99 to 8.93
|
|
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Whole Blood
|
5.78 ng eq/mL
Interval 4.1 to 7.75
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were less than (\<) lower limit of quantification.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
TAK-954
|
5.91 nanogram per milliliter (ng/mL)
Interval 5.08 to 7.79
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
THRX-513466
|
0.0143 nanogram per milliliter (ng/mL)
Interval 0.00998 to 0.0182
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Plasma
|
83.6 h*ng eq/mL
Interval 74.4 to 89.5
|
|
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Whole Blood
|
75.4 h*ng eq/mL
Interval 64.9 to 87.1
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were \< lower limit of quantification.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
TAK-954
|
55.4 hour*nanogram per milliliter (h*ng/mL)
Interval 46.2 to 66.5
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
THRX-513466
|
0.0371 hour*nanogram per milliliter (h*ng/mL)
Interval 0.00739 to 0.156
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Plasma
|
87.2 h*ng eq/mL
Interval 76.9 to 94.0
|
|
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Whole Blood
|
79.0 h*ng eq/mL
Interval 67.6 to 92.1
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set. PK data for metabolites could not be evaluated since metabolites were \< lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
|
55.7 h*ng/mL
Interval 46.4 to 66.8
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Plasma
|
1.00 hour
Interval 0.5 to 1.02
|
|
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Whole Blood
|
1.00 hour
Interval 0.55 to 1.02
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite (THRX913682) could not be evaluated since metabolites were \< lower limit of quantification.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
TAK-954
|
1.00 hour
Interval 1.0 to 1.02
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
THRX-513466
|
1.00 hour
Interval 0.55 to 1.02
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Plasma
|
70.0 hour
Interval 57.9 to 89.9
|
|
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Whole Blood
|
46.4 hour
Interval 30.2 to 73.6
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set. PK data for metabolites could not be evaluated since metabolites were \< lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
|
34.3 hour
Interval 23.1 to 47.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
|
8.97 L/h
Interval 7.49 to 10.8
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
|
444 liter
Interval 337.0 to 668.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
|
278 microgram equivalent (mcg eq)
Standard Deviation 16.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
|
157 microgram (mcg)
Standard Deviation 16.4
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
|
144 mcg eq
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
|
31.3 percentage of dose
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
|
55.6 percentage of dose
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
|
28.8 percentage of dose
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 264 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
0.50 minute
|
0.92 ratio
Standard Deviation 0.13
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
1 hour
|
0.93 ratio
Standard Deviation 0.06
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
1.5 hour
|
0.94 ratio
Standard Deviation 0.09
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
2 hour
|
0.94 ratio
Standard Deviation 0.15
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
3 hour
|
0.92 ratio
Standard Deviation 0.17
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
4 hour
|
0.96 ratio
Standard Deviation 0.06
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
6 hour
|
1.02 ratio
Standard Deviation 0.14
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
12 hour
|
1.04 ratio
Standard Deviation 0.04
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
24 hour
|
0.94 ratio
Standard Deviation 0.07
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
36 hour
|
0.97 ratio
Standard Deviation 0.11
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
72 hour
|
0.86 ratio
Standard Deviation 0.08
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
96 hour
|
0.82 ratio
Standard Deviation 0.13
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
120 hour
|
0.78 ratio
Standard Deviation 0.12
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
144 hour
|
0.79 ratio
Standard Deviation 0.21
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
168 hour
|
0.85 ratio
Standard Deviation 0.16
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
192 hour
|
1.17 ratio
Standard Deviation 0.65
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
216 hour
|
1.06 ratio
Standard Deviation 0.37
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
240 hour
|
1.04 ratio
Standard Deviation 0.35
|
|
Ratio of Total Radioactivity in Whole Blood to Plasma
264 hour
|
0.97 ratio
Standard Deviation NA
Standard deviation could not be calculated since only one participant was analyzed.
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
|
0.642 ratio
Standard Deviation 0.0741
|
SECONDARY outcome
Timeframe: Baseline up to Day 31Population: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 15Population: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
[14C]-TAK-954 0.5 mg
n=6 Participants
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
|
0.0 percentage of participants
|
Adverse Events
[14C]-TAK-954 0.5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
[14C]-TAK-954 0.5 mg
n=6 participants at risk
\[14C\]-TAK-954 0.5 mg (containing approximately 1.5 µCi) of radioactive tracer administered as a 60-minute infusion, intravenously, once on Day 1.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Head Discomfort
|
16.7%
1/6 • Number of events 1 • A treatment-emergent adverse event (TEAE) are adverse events that started after the first dose of study drug and no more than 30 days (Day 31) after receiving the study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER