Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants (NCT NCT03870555)
NCT ID: NCT03870555
Last Updated: 2020-06-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Results posted on
2020-06-24
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 08 March 2019 to 16 May 2019.
Healthy adult participants were enrolled in this 3-period cross-over study in 1 of the 3 treatment sequences to receive TAK-954 0.1 milligram (mg) or Placebo on Day 1 (Lead-in Dose), followed by TAK-954 (0.5 mg, 1 mg or 2 mg) or Placebo on Day 2 (Treatment Dose) of each study period.
Participant milestones
| Measure |
Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg
Period 1: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg infusion, intravenously, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg infusion, intravenously once on Day 2.
Period 2: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg, infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg, infusion, intravenously once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg, infusion, intravenously, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
|---|---|---|---|
|
Period 1 (2 Days)
STARTED
|
2
|
2
|
2
|
|
Period 1 (2 Days)
COMPLETED
|
2
|
2
|
2
|
|
Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period (at Least 16 Days)
STARTED
|
2
|
2
|
2
|
|
Washout Period (at Least 16 Days)
COMPLETED
|
2
|
2
|
2
|
|
Washout Period (at Least 16 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2 (2 Days)
STARTED
|
2
|
2
|
2
|
|
Period 2 (2 Days)
COMPLETED
|
2
|
2
|
2
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3 (2 Days)
STARTED
|
2
|
2
|
2
|
|
Period 3 (2 Days)
COMPLETED
|
1
|
2
|
2
|
|
Period 3 (2 Days)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg
Period 1: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg infusion, intravenously, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg infusion, intravenously once on Day 2.
Period 2: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg, infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg, infusion, intravenously once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg, infusion, intravenously, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
|---|---|---|---|
|
Period 3 (2 Days)
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Sequence 1: Placebo + TAK-954 1 mg + TAK-954 2 mg
n=2 Participants
Period 1: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg infusion, intravenously, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 2: TAK-954 0.5 mg + Placebo + TAK-954 2 mg
n=2 Participants
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg infusion, intravenously once on Day 2.
Period 2: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 2 mg, infusion, intravenously, once on Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Sequence 3: TAK-954 0.5 mg + TAK-954 1 mg + Placebo
n=2 Participants
Period 1: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 0.5 mg, infusion, intravenously once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, intravenously, once on Day 1 and TAK-954 1 mg, infusion, intravenously, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, intravenously, once on Day 1 and Day 2.
A washout period of at least 16 days was maintained between each Treatment Period.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 14.14 • n=93 Participants
|
33.0 years
STANDARD_DEVIATION 4.24 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 2.12 • n=27 Participants
|
35.8 years
STANDARD_DEVIATION 10.85 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 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
|
|
Region of Enrollment
United States
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Weight
|
84.80 kilogram
STANDARD_DEVIATION 13.152 • n=93 Participants
|
67.60 kilogram
STANDARD_DEVIATION 9.758 • n=4 Participants
|
80.55 kilogram
STANDARD_DEVIATION 0.495 • n=27 Participants
|
77.65 kilogram
STANDARD_DEVIATION 10.858 • n=483 Participants
|
|
Height
|
168.5 centimeter (cm)
STANDARD_DEVIATION 7.78 • n=93 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION 21.21 • n=4 Participants
|
165.5 centimeter (cm)
STANDARD_DEVIATION 4.95 • n=27 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION 10.43 • n=483 Participants
|
|
Body Mass Index (BMI)
|
29.655 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.9021 • n=93 Participants
|
24.375 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.5102 • n=4 Participants
|
29.455 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.7607 • n=27 Participants
|
27.828 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.1252 • n=483 Participants
|
PRIMARY outcome
Timeframe: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)Population: The safety set included all participants who received at least one dose of the study drug (active or placebo).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
|
4 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)Population: The safety set included all participants who received at least one dose of the study drug (active or placebo).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)Population: The safety set included all participants who received at least one dose of the study drug (active or placebo).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)Population: The safety set included all participants who received at least one dose of the study drug (active or placebo).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
|
88930 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 23.0
|
163200 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 12.8
|
298400 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
|
89220 pg*hr/mL
Geometric Coefficient of Variation 22.8
|
163700 pg*hr/mL
Geometric Coefficient of Variation 12.8
|
299500 pg*hr/mL
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
|
7502 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 24.1
|
15260 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 12.9
|
30270 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 28.5
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
CL: Total Clearance After Intravenous Administration for TAK-954
|
5.604 liter per hour (L/hr)
Geometric Coefficient of Variation 22.8
|
6.110 liter per hour (L/hr)
Geometric Coefficient of Variation 12.8
|
6.679 liter per hour (L/hr)
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
|
197.9 liter
Geometric Coefficient of Variation 13.7
|
387.7 liter
Geometric Coefficient of Variation 45.6
|
901.7 liter
Geometric Coefficient of Variation 61.7
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
|
104300 nanogram
Geometric Coefficient of Variation 6.3
|
226000 nanogram
Geometric Coefficient of Variation 16.0
|
408900 nanogram
Geometric Coefficient of Variation 15.3
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
|
53200 nanogram
Geometric Coefficient of Variation 27.3
|
115300 nanogram
Geometric Coefficient of Variation 19.9
|
190700 nanogram
Geometric Coefficient of Variation 23.7
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
|
32420 nanogram
Geometric Coefficient of Variation 17.3
|
66560 nanogram
Geometric Coefficient of Variation 5.3
|
103600 nanogram
Geometric Coefficient of Variation 8.5
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations). PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
|
20.86 percentage
Geometric Coefficient of Variation 6.3
|
22.60 percentage
Geometric Coefficient of Variation 16.0
|
20.45 percentage
Geometric Coefficient of Variation 15.3
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
|
10.64 percentage
Geometric Coefficient of Variation 27.3
|
11.53 percentage
Geometric Coefficient of Variation 19.9
|
9.534 percentage
Geometric Coefficient of Variation 23.7
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
|
6.484 percentage
Geometric Coefficient of Variation 17.3
|
6.656 percentage
Geometric Coefficient of Variation 5.3
|
5.181 percentage
Geometric Coefficient of Variation 8.5
|
PRIMARY outcome
Timeframe: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=3 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
CLR: Renal Clearance for TAK-954
|
3.457 L/hr
Geometric Coefficient of Variation 19.9
|
3.933 L/hr
Geometric Coefficient of Variation 8.9
|
3.624 L/hr
Geometric Coefficient of Variation 35.0
|
SECONDARY outcome
Timeframe: Day 2 dosing and at multiple time points (up to 36 hours) post-dosePopulation: The pharmacodynamic (PD) set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter.
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 2 dosing and at multiple time points (up to 36 hours) post-dosePopulation: The PD set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter.
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2
|
3.3 stools
Standard Deviation 3.40
|
2.0 stools
Standard Deviation 0.82
|
1.0 stools
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Day 2 dosing and at multiple time points (up to 36 hours) post-dosePopulation: The PD set included all participants who received at least one dose of the study drug (active or placebo) and had completed at least 1 PD sampling period and/or had at least 1 evaluable parameter.
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool form scale. The Bristol Stool Form Scale was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea.
Outcome measures
| Measure |
Treatment Dose: TAK-954 0.5 mg
n=4 Participants
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 Participants
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 Participants
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
|---|---|---|---|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 5
|
3 number of occurrences
|
1 number of occurrences
|
0 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 1
|
0 number of occurrences
|
0 number of occurrences
|
0 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 2
|
2 number of occurrences
|
3 number of occurrences
|
2 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 3
|
0 number of occurrences
|
1 number of occurrences
|
0 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 4
|
1 number of occurrences
|
2 number of occurrences
|
1 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 6
|
5 number of occurrences
|
1 number of occurrences
|
0 number of occurrences
|
|
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Type 7
|
2 number of occurrences
|
0 number of occurrences
|
0 number of occurrences
|
Adverse Events
Lead-in Dose: TAK-954 0.1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lead-in Dose: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Dose: TAK-954 0.5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment Dose: TAK-954 1 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Dose: TAK-954 2 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Dose: Placebo
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 |
Lead-in Dose: TAK-954 0.1 mg
n=6 participants at risk
TAK-954 0.1 mg, infusion, intravenously, once on Day 1 of Period 1, 2 or 3 in Sequence 1, 2, or 3.
|
Lead-in Dose: Placebo
n=6 participants at risk
TAK-954 placebo-matching, infusion, intravenously, once on Day 1 of Period 1, 2, or 3 in Sequence 1, 2, or 3.
|
Treatment Dose: TAK-954 0.5 mg
n=4 participants at risk
TAK-954 0.5 mg, infusion, intravenously, once on Day 2 of Period 1 in Sequence 2 or 3.
|
Treatment Dose: TAK-954 1 mg
n=4 participants at risk
TAK-954 1 mg, infusion, intravenously, once on Day 2 of Period 2 in Sequence 1 or 3.
|
Treatment Dose: TAK-954 2 mg
n=3 participants at risk
TAK-954 2 mg, infusion, intravenously, once on Day 2 of Period 3 in Sequence 1 or 2.
|
Treatment Dose: Placebo
n=6 participants at risk
TAK-954 placebo-matching, infusion, intravenously once on Day 2 of Period 1, 2 and 3.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
50.0%
2/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
General disorders
Catheter site pain
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
General disorders
Chills
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
General disorders
Feeling hot
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
General disorders
Thirst
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Metabolism and nutrition disorders
Increased appetite
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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
Dizziness
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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
Dysgeusia
|
33.3%
2/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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
|
50.0%
3/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
25.0%
1/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
50.0%
2/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/4 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/3 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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.
|
0.00%
0/6 • Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
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