Trial Outcomes & Findings for Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study (NCT NCT02461160)

NCT ID: NCT02461160

Last Updated: 2019-02-15

Results Overview

An Adverse Event (AE) is 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 unfavourable and unintended sign (eg, 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 is defined as an adverse event with an onset that occurs after receiving study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 88 participants
• Primary outcome timeframe: Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)
• Results posted on: 2019-02-15

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 12 May 2015 01 Aug 2016.

Healthy participants were enrolled to receive TAK-915 in any of the 5 parts of the study.

Participant milestones

Measure	SRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort 9 Group 1: A,B,C Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 10 Group 2: B,C,A Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 11 Group 3: C,A,B Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Overall Study STARTED	8	6	6	12	6	6	6	6	12	4	4	4	8
Overall Study COMPLETED	8	6	6	12	6	6	6	5	12	4	4	4	8
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0	0

Reasons for withdrawal

Measure	SRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort 9 Group 1: A,B,C Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 10 Group 2: B,C,A Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 11 Group 3: C,A,B Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	1	0	0	0	0	0

Baseline Characteristics

Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study

Baseline characteristics by cohort

Measure	SRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort 9 Group 1: A,B,C n=4 Participants Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 10 Group 2: B,C,A n=4 Participants Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period.	BA/FE Cohort 11 Group 3: C,A,B n=4 Participants Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period.	ESSD Cohort 12: TAK-915 50 mg n=8 Participants TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.	Total n=88 Participants Total of all reporting groups
Age, Continuous	35.1 Years FULL_RANGE 9.76 • n=5 Participants	37.8 Years FULL_RANGE 16.68 • n=7 Participants	41.0 Years FULL_RANGE 12.47 • n=5 Participants	31.9 Years FULL_RANGE 6.76 • n=4 Participants	35.7 Years FULL_RANGE 11.36 • n=21 Participants	33.7 Years FULL_RANGE 4.32 • n=10 Participants	37.8 Years FULL_RANGE 5.74 • n=115 Participants	38.7 Years FULL_RANGE 10.03 • n=24 Participants	38.5 Years FULL_RANGE 8.53 • n=42 Participants	35.3 Years FULL_RANGE 14.36 • n=42 Participants	37.5 Years FULL_RANGE 12.34 • n=42 Participants	37.5 Years FULL_RANGE 8.70 • n=42 Participants	68.8 Years FULL_RANGE 2.25 • n=36 Participants	39.177 Years n=36 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=36 Participants	20 Participants n=36 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	5 Participants n=24 Participants	10 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=36 Participants	68 Participants n=36 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	29 Participants n=36 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	2 Participants n=24 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=36 Participants	53 Participants n=36 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants
Body Mass Index (BMI)	27.6 kg/m^2 FULL_RANGE 4.41 • n=5 Participants	24.9 kg/m^2 FULL_RANGE 5.26 • n=7 Participants	26.1 kg/m^2 FULL_RANGE 2.95 • n=5 Participants	27.6 kg/m^2 FULL_RANGE 3.99 • n=4 Participants	27.4 kg/m^2 FULL_RANGE 1.71 • n=21 Participants	26.5 kg/m^2 FULL_RANGE 3.00 • n=10 Participants	24.4 kg/m^2 FULL_RANGE 3.95 • n=115 Participants	27.9 kg/m^2 FULL_RANGE 2.52 • n=24 Participants	28.2 kg/m^2 FULL_RANGE 2.23 • n=42 Participants	27.7 kg/m^2 FULL_RANGE 6.33 • n=42 Participants	27.0 kg/m^2 FULL_RANGE 1.52 • n=42 Participants	30.6 kg/m^2 FULL_RANGE 2.93 • n=42 Participants	28.2 kg/m^2 FULL_RANGE 2.75 • n=36 Participants	27.238 kg/m^2 n=36 Participants
Smoking History Particiapnt has never smoked	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	10 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	7 Participants n=36 Participants	73 Participants n=36 Participants
Smoking History Particiapnt is a current smoker	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants
Smoking History Participant is an ex-smoker	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	14 Participants n=36 Participants
Xanthine/caffeine history Yes	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	7 Participants n=36 Participants	43 Participants n=36 Participants
Xanthine/caffeine history No	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=24 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=36 Participants	45 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)

Population: Safety set included all participants who were enrolled and received study drug.

An Adverse Event (AE) is 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 unfavourable and unintended sign (eg, 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 is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 Participants TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A n=12 Participants TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 Participants TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 Participants TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 Participants TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)	0 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	0 percentage of participants	41.7 percentage of participants	8.3 percentage of participants	16.7 percentage of participants	0 percentage of participants	25 percentage of participants	25 percentage of participants

PRIMARY outcome

Timeframe: Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)

Population: Safety set included all participants who were enrolled and received study drug.

The percentage of participants with any markedly abnormal standard safety laboratory values, including haematology, serum chemistries, or urinalysis, during the treatment period.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 Participants TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A n=12 Participants TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 Participants TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 Participants TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 Participants TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)

Population: Safety set included all participants who were enrolled and received study drug.

The percentage of participants who meet markedly abnormal criteria for vital signs after dosing, including oral body temperature (temp.), respiration rate, pulse rate (PR) Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) for assessment in positions of supine or standing. Vital signs were considered abnormal if they were beyond the values defined in categories.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 Participants TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A n=12 Participants TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 Participants TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 Participants TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 Participants TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 minute SBP, <85 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 minutes SBP, >180 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 minutes SBP(mmHg), <85 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 minutes SBP, >180 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 minutes SBP, <85 mmHg	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	8.3 percentage of participants	8.3 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 minutes SBP, >180 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 minute DBP, <50 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 minute DBP, >110 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 minutes DBP, <50 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 minutes DBP, >110 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 minutes DBP, <50 mmHg	12.5 percentage of participants	0 percentage of participants	16.7 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	8.3 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 minutes DBP, >110 mmHg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 min PR, <50 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 min PR, >120 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 mins PR, <50 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 mins PR, >120 beats/min	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	8.3 percentage of participants	8.3 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 mins PR, <50 beats/min	25 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	50 percentage of participants	50 percentage of participants	50 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 mins PR, >120 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 min Temperature, <35.6 °C	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 1 min Temperature, >37.7 °C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 mins Temperature, <35.6 °C	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Standing, after 3 mins Temperature, >37.7 °C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 mins Temperature, <35.6 °C	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Measurements Supine, after 5 mins Temperature, >37.7 °C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)

Population: Safety set included all participants who were enrolled and received study drug.

The percentage of participants who meet markedly abnormal criteria for ECG parameters as specified by the protocol and statistical analysis plan during the treatment period. ECG parameters were considered abnormal if they were beyond the values defined in categories.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 Participants TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 Participants Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A n=12 Participants TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 Participants TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 Participants TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 Participants TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Heart Rate, <50 beats/min	37.5 percentage of participants	0 percentage of participants	16.7 percentage of participants	25 percentage of participants	66.7 percentage of participants	50 percentage of participants	50 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Heart Rate, >120 beats/min	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters PR Interval, <=80 msec (ms)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters PR Interval, >=200 ms	12.5 percentage of participants	16.7 percentage of participants	0 percentage of participants	8.3 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	8.3 percentage of participants	8.3 percentage of participants	16.7 percentage of participants	25 percentage of participants	25 percentage of participants	8.3 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QRS Interval, <=80 ms	12.5 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	8.3 percentage of participants	25.0 percentage of participants	25.0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	8.3 percentage of participants	25 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QRS Interval, >=180 ms	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QT Interval, <=300 ms	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QT Interval, >=460 ms	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QTcB Interval, <=300 ms	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QTcB Interval,≥500ms OR ≥450ms and ≥30ms CFB	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QTcF Interval, <= 300 ms	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters QTcF Interval, ≥500 msec OR ≥ 450 msec and ≥30 CFB	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 Day 1	1.750 hr Interval 1.5 to 6.0	2.000 hr Interval 0.5 to 4.0	2.000 hr Interval 1.0 to 3.0	2.508 hr Interval 1.0 to 6.1	1.500 hr Interval 1.5 to 3.0	1.500 hr Interval 1.0 to 4.0	3.058 hr Interval 3.0 to 6.0	1.500 hr Interval 1.0 to 2.0	—	—	—	—	—	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 Day 8	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	1.500 hr Interval 1.5 to 2.0	2.000 hr Interval 1.5 to 4.0	2.00 hr Interval 1.5 to 3.0	NA hr Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 Day 14	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	NA hr Data was not analysed for this arm group at the given time point.	1.500 hr Interval 1.5 to 1.52	2.500 hr Interval 1.0 to 4.0	3.000 hr Interval 1.0 to 4.0	NA hr Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Cmax: Maximum Observed Plasma Concentration for TAK-915 Day 1	203.7 ng/mL Standard Deviation 42.77 • Interval 1.5 to 6.0	654.8 ng/mL Standard Deviation 145.97 • Interval 0.5 to 4.0	417.3 ng/mL Standard Deviation 96.27 • Interval 1.0 to 3.0	675.8 ng/mL Standard Deviation 168.66 • Interval 1.0 to 6.1	209.5 ng/mL Standard Deviation 46.60 • Interval 1.5 to 3.0	651.8 ng/mL Standard Deviation 227.77 • Interval 1.0 to 4.0	743.8 ng/mL Standard Deviation 148.45 • Interval 3.0 to 6.0	414.0 ng/mL Standard Deviation 106.43 • Interval 1.0 to 2.0	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-915 Day 8	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	196.0 ng/mL Standard Deviation 47.72 • Interval 1.5 to 2.0	651.0 ng/mL Standard Deviation 130.51 • Interval 1.5 to 4.0	836.7 ng/mL Standard Deviation 220.01 • Interval 1.5 to 3.0	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-915 Day 14	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	397.5 ng/mL Standard Deviation 137.14 • Interval 1.5 to 1.52	1081.0 ng/mL Standard Deviation 170.94 • Interval 1.0 to 4.0	1865.0 ng/mL Standard Deviation 334.71 • Interval 1.0 to 4.0	NA ng/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 Day 1	2560.0 ng*hr/mL Standard Deviation 631.76 • Interval 1.5 to 6.0	8293.3 ng*hr/mL Standard Deviation 1430.62 • Interval 0.5 to 4.0	5478.1 ng*hr/mL Standard Deviation 729.80 • Interval 1.0 to 3.0	10285.1 ng*hr/mL Standard Deviation 1515.01 • Interval 1.0 to 6.1	2610.0 ng*hr/mL Standard Deviation 534.55 • Interval 1.5 to 3.0	7984.6 ng*hr/mL Standard Deviation 1437.41 • Interval 1.0 to 4.0	11640.5 ng*hr/mL Standard Deviation 1889.06 • Interval 3.0 to 6.0	4693.0 ng*hr/mL Standard Deviation 637.27 • Interval 1.0 to 2.0	—	—	—	—	—	—	—
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 Day 8	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	2301.7 ng*hr/mL Standard Deviation 782.55 • Interval 1.5 to 2.0	8333.9 ng*hr/mL Standard Deviation 890.57 • Interval 1.5 to 4.0	12549.3 ng*hr/mL Standard Deviation 3355.02 • Interval 1.5 to 3.0	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 Day 14	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	5688.9 ng*hr/mL Standard Deviation 2759.15 • Interval 1.5 to 1.52	15068.7 ng*hr/mL Standard Deviation 2367.02 • Interval 1.0 to 4.0	31656.0 ng*hr/mL Standard Deviation 5574.82 • Interval 1.0 to 4.0	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 Day 1	5187.3 ng*hr/mL Standard Deviation 956.99	18229.5 ng*hr/mL Standard Deviation 5124.97	10812.4 ng*hr/mL Standard Deviation 1098.50	24204.7 ng*hr/mL Standard Deviation 3870.08	5380.9 ng*hr/mL Standard Deviation 2065.75	15640.0 ng*hr/mL Standard Deviation 2998.50	30251.6 ng*hr/mL Standard Deviation 4473.58	11552.2 ng*hr/mL Standard Deviation 2214.35	—	—	—	—	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 Day 8	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	2301.7 ng*hr/mL Standard Deviation 782.55	8334.6 ng*hr/mL Standard Deviation 890.88	12549.3 ng*hr/mL Standard Deviation 3355.02	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 Day 14	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	12653.2 ng*hr/mL Standard Deviation 8536.11	27924.7 ng*hr/mL Standard Deviation 7330.59	67706.4 ng*hr/mL Standard Deviation 22451.23	NA ng*hr/mL Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915	6197.1 ng*hr/mL Standard Deviation 1102.70 • Interval 1.5 to 6.0	19345.6 ng*hr/mL Standard Deviation 5548.95 • Interval 0.5 to 4.0	12198.3 ng*hr/mL Standard Deviation 1312.58 • Interval 1.0 to 3.0	30243.3 ng*hr/mL Standard Deviation 7208.93 • Interval 1.0 to 6.1	6565.6 ng*hr/mL Standard Deviation 3237.81 • Interval 1.5 to 3.0	17507.2 ng*hr/mL Standard Deviation 4461.40 • Interval 1.0 to 4.0	40326.7 ng*hr/mL Standard Deviation 11260.16 • Interval 3.0 to 6.0	16991.5 ng*hr/mL Standard Deviation 4349.17 • Interval 1.0 to 2.0	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Rac(AUC): Accumulation Ratios Between Day 14 AUC(0-24) and Day 1 AUC(0-24) for TAK-915	2.100 Ratio Standard Deviation 0.6568	1.973 Ratio Standard Deviation 0.6523	2.761 Ratio Standard Deviation 0.5207	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Rac(Cmax): Accumulation Ratios Between Day 14 Cmax and Day 1 Cmax for TAK-915	1.884 Ratio Standard Deviation 0.4627	1.859 Ratio Standard Deviation 0.7642	2.556 Ratio Standard Deviation 0.5148	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Time Dependency Assessment From AUC(0-24) After Last Dose for TAK-915 on Day 14 in MRD Cohorts Compared to AUC(0-inf) After a Single Dose on Day 1	0.873 ratio Standard Deviation 0.1342	0.883 ratio Standard Deviation 0.1441	0.846 ratio Standard Deviation 0.1463	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Cmax: Maximum Observed Plasma Concentration for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort Day 1	9.6 ng/mL Standard Deviation 3.02	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort Day 16	8.3 ng/mL Standard Deviation 2.17	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort Day 1	25.0 ng*hr/mL Standard Deviation 10.09	—	—	—	—	—	—	—	—	—	—	—	—	—	—
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort Day 16	17.4 ng*hr/mL Standard Deviation 5.48	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-24) for Midazolam After Single Dose (Day 1)/AUC(0-24) for Midazolam After 7 Daily Doses of TAK-915 (Day 16) in DDI Cohort	0.735 Ratio Standard Deviation 0.1509	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Terminal Elimination Half-life (t1/2) for TAK-915 Day 1	35.246 hr Full Range 42.77 • Interval 22.74 to 55.6	34.008 hr Full Range 145.97 • Interval 27.05 to 85.65	32.621 hr Full Range 96.27 • Interval 23.02 to 39.02	37.826 hr Full Range 168.66 • Interval 29.5 to 55.78	37.166 hr Full Range 46.60 • Interval 20.08 to 50.02	23.326 hr Full Range 227.77 • Interval 18.77 to 46.44	46.408 hr Full Range 148.45 • Interval 24.33 to 78.31	61.244 hr Full Range 106.43 • Interval 27.71 to 75.78	—	—	—	—	—	—	—
Terminal Elimination Half-life (t1/2) for TAK-915 Day 14	NA hr Full Range NA Data was not analysed for this arm group at the given time point.	NA hr Full Range NA Data was not analysed for this arm group at the given time point.	NA hr Full Range NA Data was not analysed for this arm group at the given time point.	NA hr Full Range NA Data was not analysed for this arm group at the given time point.	32.770 hr Full Range 137.14 • Interval 22.97 to 61.4	23.517 hr Full Range 170.94 • Interval 17.57 to 28.73	35.503 hr Full Range 334.71 • Interval 24.75 to 54.51	NA hr Full Range NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. Number of participants analysed is the participants who were evaluable in each cohort.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=5 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
CL/F: Apparent Clearance for TAK-915 Day 1	4.966 L/hr Standard Deviation 0.8498 • Interval 22.74 to 55.6	5.565 L/hr Standard Deviation 1.7418 • Interval 27.05 to 85.65	16.566 L/hr Standard Deviation 1.9026 • Interval 23.02 to 39.02	6.928 L/hr Standard Deviation 1.5930 • Interval 29.5 to 55.78	5.437 L/hr Standard Deviation 2.3306 • Interval 20.08 to 50.02	5.993 L/hr Standard Deviation 1.3303 • Interval 18.77 to 46.44	5.313 L/hr Standard Deviation 1.6232 • Interval 24.33 to 78.31	5.651 L/hr Standard Deviation 2.3825 • Interval 27.71 to 75.78	—	—	—	—	—	—	—
CL/F: Apparent Clearance for TAK-915 Day 14	NA L/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	6.289 L/hr Standard Deviation 2.6024 • Interval 22.97 to 61.4	6.791 L/hr Standard Deviation 1.1948 • Interval 17.57 to 28.73	6.625 L/hr Standard Deviation 1.2982 • Interval 24.75 to 54.51	NA L/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Apparent Volume of Distribution (Vz/F) for TAK-915 Day 1	271.621 L Standard Deviation 81.4842 • Interval 22.74 to 55.6	253.274 L Standard Deviation 44.1565 • Interval 27.05 to 85.65	739.900 L Standard Deviation 138.9342 • Interval 23.02 to 39.02	384.373 L Standard Deviation 54.7107 • Interval 29.5 to 55.78	253.191 L Standard Deviation 43.9653 • Interval 20.08 to 50.02	219.807 L Standard Deviation 44.0421 • Interval 18.77 to 46.44	289.052 L Standard Deviation 33.6825 • Interval 24.33 to 78.31	251.206 L Standard Deviation 28.7250 • Interval 27.71 to 75.78	—	—	—	—	—	—	—
Apparent Volume of Distribution (Vz/F) for TAK-915 Day 14	NA L Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA L Standard Deviation NA Data was not analysed for this arm group at the given time point.	290.034 L Standard Deviation 47.4883 • Interval 22.97 to 61.4	231.463 L Standard Deviation 38.5789 • Interval 17.57 to 28.73	373.816 L Standard Deviation 143.239 • Interval 24.75 to 54.51	NA L Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Total Amount of Drug Excreted in Urine (Ae) for TAK-915 Day 1	10716.238 ng Standard Deviation 6732.8265 • Interval 22.74 to 55.6	56307.372 ng Standard Deviation 22847.5616 • Interval 27.05 to 85.65	39016.323 ng Standard Deviation 39432.2098 • Interval 23.02 to 39.02	70789.157 ng Standard Deviation 31812.6780 • Interval 29.5 to 55.78	11637.538 ng Standard Deviation 7559.7833 • Interval 20.08 to 50.02	75873.405 ng Standard Deviation 57990.3620 • Interval 18.77 to 46.44	84953.950 ng Standard Deviation 28044.2529 • Interval 24.33 to 78.31	—	—	—	—	—	—	—	—
Total Amount of Drug Excreted in Urine (Ae) for TAK-915 Day 14	NA ng Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ng Standard Deviation NA Data was not analysed for this arm group at the given time point.	23712.223 ng Standard Deviation 16960.3220 • Interval 22.97 to 61.4	107635.360 ng Standard Deviation 66665.1502 • Interval 17.57 to 28.73	173279.223 ng Standard Deviation 102551.0702 • Interval 24.75 to 54.51	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Fraction of Drug Excreted in Urine (Fe) for TAK-915 Day 1	0.036 fraction excreted Standard Deviation 0.0224 • Interval 22.74 to 55.6	0.056 fraction excreted Standard Deviation 0.0228 • Interval 27.05 to 85.65	0.020 fraction excreted Standard Deviation 0.0197 • Interval 23.02 to 39.02	0.035 fraction excreted Standard Deviation 0.0159 • Interval 29.5 to 55.78	0.039 fraction excreted Standard Deviation 0.0252 • Interval 20.08 to 50.02	0.076 fraction excreted Standard Deviation 0.0580 • Interval 18.77 to 46.44	0.042 fraction excreted Standard Deviation 0.0140 • Interval 24.33 to 78.31	—	—	—	—	—	—	—	—
Fraction of Drug Excreted in Urine (Fe) for TAK-915 Day 14	NA fraction excreted Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA fraction excreted Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA fraction excreted Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA fraction excreted Standard Deviation NA Data was not analysed for this arm group at the given time point.	0.079 fraction excreted Standard Deviation 0.0565 • Interval 22.97 to 61.4	0.108 fraction excreted Standard Deviation 0.0667 • Interval 17.57 to 28.73	0.099 fraction excreted Standard Deviation 0.0471 • Interval 24.75 to 54.51	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Renal Clearance (CLr) for TAK-915 Day 14	NA mL/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA mL/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA mL/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA mL/hr Standard Deviation NA Data was not analysed for this arm group at the given time point.	2.208 mL/hr Standard Deviation 0.8706 • Interval 22.97 to 61.4	4.696 mL/hr Standard Deviation 4.5467 • Interval 17.57 to 28.73	3.246 mL/hr Standard Deviation 2.0065 • Interval 24.75 to 54.51	—	—	—	—	—	—	—	—
Renal Clearance (CLr) for TAK-915 Day 1	2.140 mL/hr Standard Deviation 1.3783 • Interval 22.74 to 55.6	3.191 mL/hr Standard Deviation 1.1645 • Interval 27.05 to 85.65	3.612 mL/hr Standard Deviation 3.5780 • Interval 23.02 to 39.02	2.915 mL/hr Standard Deviation 1.3632 • Interval 29.5 to 55.78	2.265 mL/hr Standard Deviation 1.7248 • Interval 20.08 to 50.02	5.047 mL/hr Standard Deviation 4.2166 • Interval 18.77 to 46.44	2.934 mL/hr Standard Deviation 1.2499 • Interval 24.33 to 78.31	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Cmax: Maximum Observed Plasma Concentration for TAK-915 on Day 1 in DDI Cohort	519.7 ng/mL Standard Deviation 156.12	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 on Day 1 in DDI Cohort	7324.5 ng*hr/mL Standard Deviation 2130.73	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 16 at multiple time points (up to 96 hours) post dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-tau): Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval Where Tau is the Length of the Dosing Interval for TAK-915 in DDI Cohort	17093.9 ng*hr/mL Standard Deviation 5803.03	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=8 Participants TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Ratio of TAK-915 Metabolite Cmax to TAK-915 Cmax in SRD and MRD Cohorts Day 1	0.230 ratio Standard Deviation 0.0281 • Interval 22.74 to 55.6	0.248 ratio Standard Deviation 0.0440 • Interval 27.05 to 85.65	0.254 ratio Standard Deviation 0.0287 • Interval 23.02 to 39.02	0.273 ratio Standard Deviation 0.0550 • Interval 29.5 to 55.78	0.212 ratio Standard Deviation 0.0410 • Interval 20.08 to 50.02	0.267 ratio Standard Deviation 0.0454 • Interval 18.77 to 46.44	0.277 ratio Standard Deviation 0.0632 • Interval 24.33 to 78.31	0.207 ratio Standard Deviation 0.0326 • Interval 27.71 to 75.78	—	—	—	—	—	—	—
Ratio of TAK-915 Metabolite Cmax to TAK-915 Cmax in SRD and MRD Cohorts Day 14	NA ratio Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ratio Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ratio Standard Deviation NA Data was not analysed for this arm group at the given time point.	NA ratio Standard Deviation NA Data was not analysed for this arm group at the given time point.	0.356 ratio Standard Deviation 0.0609 • Interval 22.97 to 61.4	0.480 ratio Standard Deviation 0.0764 • Interval 17.57 to 28.73	0.0764 ratio Standard Deviation 0.0690 • Interval 24.75 to 54.51	NA ratio Standard Deviation NA Data was not analysed for this arm group at the given time point.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=6 Participants TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=8 Participants TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Ratio of TAK-915 Metabolite AUC(0-inf) to TAK-915 AUC(0-inf) in SRD Cohorts	0.492 ratio Standard Deviation 0.1179 • Interval 22.74 to 55.6	0.475 ratio Standard Deviation 0.1029 • Interval 27.05 to 85.65	0.483 ratio Standard Deviation 0.1037 • Interval 23.02 to 39.02	0.576 ratio Standard Deviation 0.1071 • Interval 29.5 to 55.78	0.451 ratio Standard Deviation 0.1334 • Interval 27.71 to 75.78	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 14 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=6 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Ratio of TAK-915 Metabolite Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval [AUC(0-tau)] Where Tau is the Length of the Dosing Interval to TAK-915 AUC(0-tau) in MRD Cohorts	0.496 ratio Standard Deviation 0.1177 • Interval 20.08 to 50.02	0.640 ratio Standard Deviation 0.1177 • Interval 18.77 to 46.44	0.505 ratio Standard Deviation 0.0940 • Interval 24.33 to 78.31	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Cmax: Maximum Observed Plasma Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	337.0 ng/mL Standard Deviation 337.0	208.0 ng/mL Standard Deviation 68.48	143.4 ng/mL Standard Deviation 55.03	—	—	—	—	—	—	—	—	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	79.2 ng/mL Standard Deviation 18.55	48.9 ng/mL Standard Deviation 13.21	34.6 ng/mL Standard Deviation 16.03	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	8412.3 ng*hr/mL Standard Deviation 2019.40	7310.0 ng*hr/mL Standard Deviation 1928.95	5740.2 ng*hr/mL Standard Deviation 2227.13	—	—	—	—	—	—	—	—	—	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	3785.3 ng*hr/mL Standard Deviation 771.24	2992.1 ng*hr/mL Standard Deviation 582.21	2208.7 ng*hr/mL Standard Deviation 888.83	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	10155.2 ng*hr/mL Standard Deviation 2909.10	9414.5 ng*hr/mL Standard Deviation 9414.5	7151.5 ng*hr/mL Standard Deviation 2836.73	—	—	—	—	—	—	—	—	—	—	—	—
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	4727.2 ng*hr/mL Standard Deviation 1073.11	4145.2 ng*hr/mL Standard Deviation 1027.33	3011.6 ng*hr/mL Standard Deviation 1315.23	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	1.500 hr Interval 1.0 to 3.4	3.000 hr Interval 1.5 to 6.0	7.000 hr Interval 4.08 to 24.0	—	—	—	—	—	—	—	—	—	—	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	2.250 hr Interval 1.0 to 12.0	10.000 hr Interval 2.0 to 24.0	24.000 hr Interval 10.0 to 32.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Terminal Elimination Half-life (t1/2) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	34.973 hr Interval 19.83 to 52.65	45.359 hr Interval 21.43 to 63.71	40.101 hr Interval 19.46 to 53.53	—	—	—	—	—	—	—	—	—	—	—	—
Terminal Elimination Half-life (t1/2) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	39.937 hr Interval 19.68 to 68.78	50.010 hr Interval 19.55 to 142.18	48.406 hr Interval 19.43 to 76.85	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose

Population: Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.

Outcome measures

Measure	SRD Cohorts Pooled Placebo n=12 Participants TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=12 Participants TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=12 Participants TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915).	BA/FE Cohort Regimen A TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
λz: Terminal Elimination Rate Constant for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort TAK-915	0.0202 1/hr Standard Deviation 0.00623	0.0187 1/hr Standard Deviation 0.00677	0.0202 1/hr Standard Deviation 0.00702	—	—	—	—	—	—	—	—	—	—	—	—
λz: Terminal Elimination Rate Constant for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort Metabolite M-I	0.0180 1/hr Standard Deviation 0.00665	0.0155 1/hr Standard Deviation 0.00834	0.0162 1/hr Standard Deviation 0.00748	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

SRD Cohorts Pooled Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SRD Cohort 1 TAK-915 30 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

SRD Cohort 2: TAK-915 100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SRD Cohort 3: TAK-915 200 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MRD Cohorts Pooled Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MRD Cohort 5: TAK-915 30 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MRD Cohort 6: TAK-915 100 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MRD Cohort 7: TAK-915 200 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

DDI Cohort 8: Midazolam 2 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DDI Cohort 8: TAK-915 100 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

DDI Cohort 8: TAK-915 + Midazolam 2 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

BA/FE Cohort Regimen A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BA/FE Cohort Regimen B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BA/FE Cohort Regimen C

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ESSD Cohort 12: TAK-915 50 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	SRD Cohorts Pooled Placebo n=8 participants at risk TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 participants at risk TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 participants at risk TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 participants at risk TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 participants at risk TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 participants at risk TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 participants at risk TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 participants at risk TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 participants at risk Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 participants at risk TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 participants at risk Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915)	BA/FE Cohort Regimen A n=12 participants at risk TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 participants at risk TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 participants at risk TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 participants at risk TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Nervous system disorders Anxiety	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.

Other adverse events

Measure	SRD Cohorts Pooled Placebo n=8 participants at risk TAK-915 placebo-matching suspension, orally, once on Day 1.	SRD Cohort 1 TAK-915 30 mg n=6 participants at risk TAK-915 30 mg suspension, orally, once on Day 1.	SRD Cohort 2: TAK-915 100 mg n=6 participants at risk TAK-915 100 mg suspension, orally, once on Day 1.	SRD Cohort 3: TAK-915 200 mg n=12 participants at risk TAK-915 200 mg suspension, orally, once on Day 1.	MRD Cohorts Pooled Placebo n=6 participants at risk TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14.	MRD Cohort 5: TAK-915 30 mg n=6 participants at risk TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 6: TAK-915 100 mg n=6 participants at risk TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14.	MRD Cohort 7: TAK-915 200 mg n=6 participants at risk TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14.	DDI Cohort 8: Midazolam 2 mg n=12 participants at risk Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915).	DDI Cohort 8: TAK-915 100 mg n=12 participants at risk TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16.	DDI Cohort 8: TAK-915 + Midazolam 2 mg n=12 participants at risk Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915)	BA/FE Cohort Regimen A n=12 participants at risk TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period.	BA/FE Cohort Regimen B n=12 participants at risk TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period.	BA/FE Cohort Regimen C n=12 participants at risk TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period.	ESSD Cohort 12: TAK-915 50 mg n=8 participants at risk TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Nervous system disorders Headache	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 2/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	12.5% 1/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
General disorders Chest discomfort	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Renal and urinary disorders Chromaturia	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Nervous system disorders Dizziness	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Gastrointestinal disorders Nausea	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
General disorders Application site irritation	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 2/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Gastrointestinal disorders Faeces hard	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Gastrointestinal disorders Infrequent bowel movements	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 1/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	16.7% 2/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Infections and infestations Nasopharyngitis	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Nervous system disorders Syncope	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Injury, poisoning and procedural complications Injury	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	12.5% 1/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
General disorders Influenza like illness	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/6 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	8.3% 1/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/12 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.	0.00% 0/8 • Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the regimen received by the participants.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

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