Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy (NCT NCT03748979)

Last Updated: 2020-12-08

Results Overview

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

57 participants

Primary outcome timeframe

From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)

Results posted on

2020-12-08

Participant Flow

Participants took part in the study at 3 investigative sites in Japan from 21 November 2018 to 24 October 2019.

Healthy participants were enrolled in Part A and A' (exploratory), NT1 in Part B and NT2 in Part C, to receive TAK-925 multiple rising dose of 44 mg (milligram), 112 mg,180 mg or placebo in Part A, 11 mg, 44 mg or placebo in Part B, multiple dose of TAK-925 44 mg, 112 mg or placebo in Part C.

Participant milestones

Participant milestones
Measure	Part A, Cohorts A1-A3: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 1 (NT1) participants.	Part B, Cohort B1: TAK-925 11 mg TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 2 (NT2) participants.	Part C, Cohort C1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Overall Study STARTED	6	6	6	6	4	4	5	5	4	5	6
Overall Study COMPLETED	6	6	6	6	4	4	5	5	4	5	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=6 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=4 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo n=5 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg n=4 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg n=5 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg n=6 Participants TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.	Total n=57 Participants Total of all reporting groups
Weight	64.58 kilogram (kg) STANDARD_DEVIATION 5.486 • n=6 Participants	62.75 kilogram (kg) STANDARD_DEVIATION 3.250 • n=6 Participants	63.72 kilogram (kg) STANDARD_DEVIATION 7.392 • n=6 Participants	63.60 kilogram (kg) STANDARD_DEVIATION 7.987 • n=6 Participants	72.90 kilogram (kg) STANDARD_DEVIATION 13.071 • n=4 Participants	75.20 kilogram (kg) STANDARD_DEVIATION 18.150 • n=4 Participants	70.32 kilogram (kg) STANDARD_DEVIATION 15.554 • n=5 Participants	56.20 kilogram (kg) STANDARD_DEVIATION 11.689 • n=5 Participants	57.73 kilogram (kg) STANDARD_DEVIATION 13.072 • n=4 Participants	61.68 kilogram (kg) STANDARD_DEVIATION 10.055 • n=5 Participants	60.60 kilogram (kg) STANDARD_DEVIATION 4.549 • n=6 Participants	64.14 kilogram (kg) STANDARD_DEVIATION 10.706 • n=57 Participants
Age, Continuous	24.8 years STANDARD_DEVIATION 4.71 • n=6 Participants	24.7 years STANDARD_DEVIATION 3.88 • n=6 Participants	23.8 years STANDARD_DEVIATION 3.54 • n=6 Participants	22.3 years STANDARD_DEVIATION 0.52 • n=6 Participants	28.3 years STANDARD_DEVIATION 9.18 • n=4 Participants	38.0 years STANDARD_DEVIATION 3.92 • n=4 Participants	27.6 years STANDARD_DEVIATION 8.20 • n=5 Participants	31.8 years STANDARD_DEVIATION 11.14 • n=5 Participants	31.3 years STANDARD_DEVIATION 7.50 • n=4 Participants	25.0 years STANDARD_DEVIATION 5.87 • n=5 Participants	21.7 years STANDARD_DEVIATION 2.88 • n=6 Participants	26.6 years STANDARD_DEVIATION 7.04 • n=57 Participants
Sex: Female, Male Female	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=5 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=5 Participants	0 Participants n=6 Participants	13 Participants n=57 Participants
Sex: Female, Male Male	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=4 Participants	2 Participants n=4 Participants	3 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=5 Participants	6 Participants n=6 Participants	44 Participants n=57 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=4 Participants	4 Participants n=4 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=5 Participants	6 Participants n=6 Participants	57 Participants n=57 Participants
Body Mass Index (BMI)	22.42 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 0.968 • n=6 Participants	21.12 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 1.030 • n=6 Participants	22.37 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 1.960 • n=6 Participants	21.87 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 2.360 • n=6 Participants	24.83 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 2.378 • n=4 Participants	27.33 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 4.955 • n=4 Participants	24.68 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 4.791 • n=5 Participants	20.88 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 3.565 • n=5 Participants	22.83 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 4.213 • n=4 Participants	22.18 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 3.489 • n=5 Participants	21.05 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 1.174 • n=6 Participants	22.66 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 3.210 • n=57 Participants
Height	170.2 centimeter (cm) STANDARD_DEVIATION 4.71 • n=6 Participants	173.3 centimeter (cm) STANDARD_DEVIATION 4.84 • n=6 Participants	168.8 centimeter (cm) STANDARD_DEVIATION 5.85 • n=6 Participants	170.8 centimeter (cm) STANDARD_DEVIATION 4.71 • n=6 Participants	169.8 centimeter (cm) STANDARD_DEVIATION 7.80 • n=4 Participants	165.3 centimeter (cm) STANDARD_DEVIATION 8.18 • n=4 Participants	166.8 centimeter (cm) STANDARD_DEVIATION 7.56 • n=5 Participants	162.2 centimeter (cm) STANDARD_DEVIATION 5.02 • n=5 Participants	158.0 centimeter (cm) STANDARD_DEVIATION 5.60 • n=4 Participants	164.6 centimeter (cm) STANDARD_DEVIATION 5.46 • n=5 Participants	170.7 centimeter (cm) STANDARD_DEVIATION 3.44 • n=6 Participants	167.8 centimeter (cm) STANDARD_DEVIATION 6.63 • n=57 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)

Population: The safety set was defined as all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=6 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=4 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo n=5 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg n=4 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg n=5 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg n=6 Participants TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	1 Participants	0 Participants	2 Participants	4 Participants	1 Participants	1 Participants	5 Participants	0 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf

Population: The pharmacokinetic (PK) set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.

This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.

Outcome measures

Outcome measures
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=4 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=5 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 Day 1	74.49 nanogram per milliliter (ng/mL) Standard Deviation 4.3433	166.9 nanogram per milliliter (ng/mL) Standard Deviation 20.995	300.2 nanogram per milliliter (ng/mL) Standard Deviation 50.532	17.39 nanogram per milliliter (ng/mL) Standard Deviation 1.2842	70.20 nanogram per milliliter (ng/mL) Standard Deviation 18.798	68.74 nanogram per milliliter (ng/mL) Standard Deviation 7.3623	156.1 nanogram per milliliter (ng/mL) Standard Deviation 29.210	—	—	—	—
Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 Day 7	70.31 nanogram per milliliter (ng/mL) Standard Deviation 8.4434	159.2 nanogram per milliliter (ng/mL) Standard Deviation 23.560	295.5 nanogram per milliliter (ng/mL) Standard Deviation 46.173	17.68 nanogram per milliliter (ng/mL) Standard Deviation 1.7176	73.20 nanogram per milliliter (ng/mL) Standard Deviation 14.980	70.87 nanogram per milliliter (ng/mL) Standard Deviation 7.4375	153.9 nanogram per milliliter (ng/mL) Standard Deviation 24.876	—	—	—	—

SECONDARY outcome

Population: The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter.

This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.

Outcome measures

Outcome measures
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=4 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=5 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925 Day 1	662.4 hournanogram per milliliter (hng/mL) Standard Deviation 70.718	1516 hournanogram per milliliter (hng/mL) Standard Deviation 151.45	2615 hournanogram per milliliter (hng/mL) Standard Deviation 392.89	164.2 hournanogram per milliliter (hng/mL) Standard Deviation 18.257	682.3 hournanogram per milliliter (hng/mL) Standard Deviation 126.81	648.3 hournanogram per milliliter (hng/mL) Standard Deviation 80.748	1496 hournanogram per milliliter (hng/mL) Standard Deviation 279.16	—	—	—	—
Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925 Day 7	650.7 hournanogram per milliliter (hng/mL) Standard Deviation 78.156	1523 hournanogram per milliliter (hng/mL) Standard Deviation 174.40	2747 hournanogram per milliliter (hng/mL) Standard Deviation 372.96	182.7 hournanogram per milliliter (hng/mL) Standard Deviation 22.603	722.7 hournanogram per milliliter (hng/mL) Standard Deviation 102.28	657.1 hournanogram per milliliter (hng/mL) Standard Deviation 72.833	1519 hournanogram per milliliter (hng/mL) Standard Deviation 248.46	—	—	—	—

SECONDARY outcome

Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.

Outcome measures

Outcome measures
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=4 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=5 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925	0.9832 ratio Standard Deviation 0.041034	1.009 ratio Standard Deviation 0.080171	1.050 ratio Standard Deviation 0.020000	1.118 ratio Standard Deviation 0.14637	1.062 ratio Standard Deviation 0.066062	1.017 ratio Standard Deviation 0.098127	1.018 ratio Standard Deviation 0.030760	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 1 and Day 7

Population: The pharmacodynamic (PD) set was defined as all participants who received at least one dose of study drug. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points.

The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.

Outcome measures

Outcome measures
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=4 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=4 Participants TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=5 Participants TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=5 Participants TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=4 Participants TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=5 Participants TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 Baseline	1.97 minutes Standard Deviation 0.850	2.03 minutes Standard Deviation 0.717	5.23 minutes Standard Deviation 4.029	4.13 minutes Standard Deviation 3.280	6.83 minutes Standard Deviation 3.924	7.33 minutes Standard Deviation 5.932	—	—	—	—	—
Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 Change at Day 7	-0.38 minutes Standard Deviation 0.621	21.00 minutes Standard Deviation 12.141	34.78 minutes Standard Deviation 4.029	2.35 minutes Standard Deviation 3.369	25.79 minutes Standard Deviation 7.544	28.28 minutes Standard Deviation 4.886	—	—	—	—	—
Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 Change at Day 1	-0.66 minutes Standard Deviation 0.892	35.13 minutes Standard Deviation 4.268	34.19 minutes Standard Deviation 4.398	2.58 minutes Standard Deviation 3.751	23.88 minutes Standard Deviation 2.955	31.15 minutes Standard Deviation 5.507	—	—	—	—	—

Deaths: 0 deaths

Part A', Cohort A'1: TAK-925 112 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A, Cohorts A1-A3: Pooled Placebo n=6 participants at risk TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A1: TAK-925 44 mg n=6 participants at risk TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A2: TAK-925 112 mg n=6 participants at risk TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part A, Cohort A3: TAK-925 180 mg n=6 participants at risk TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.	Part B, Cohorts B1-B2: Pooled Placebo n=4 participants at risk TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B1: TAK-925 11 mg n=4 participants at risk TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part B, Cohort B2: TAK-925 44 mg n=5 participants at risk TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants.	Part C, Cohorts C1-C2: Pooled Placebo n=5 participants at risk TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C1: TAK-925 44 mg n=4 participants at risk TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part C, Cohort C2: TAK-925 112 mg n=5 participants at risk TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants.	Part A', Cohort A'1: TAK-925 112 mg n=6 participants at risk TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants.
Infections and infestations Nasopharyngitis	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 Salivary hypersecretion	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 abnormal	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 Asthenia	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 Dermatitis contact	16.7% 1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.
Vascular disorders Hot flush	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	80.0% 4/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	40.0% 2/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 Hyperhidrosis	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 Gastroenteritis	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.
Investigations Blood pressure increased	0.00% 0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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% 0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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.	20.0% 1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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 • TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) 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

Medical director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

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