Trial Outcomes & Findings for TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus (NCT NCT02430870)

NCT ID: NCT02430870

Last Updated: 2016-08-31

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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Up to Day 34
• Results posted on: 2016-08-31

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 02 April 2015 to 04 November 2015.

Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) were enrolled in 1 of 3 treatment groups: placebo, 0.35 mg or 0.80 mg TAK-648 in Part 1. Healthy Japanese volunteers were enrolled in 1 of 5 treatment groups: placebo, 0.05 mg, 0.15 mg, 0.35 mg or 0.80 mg TAK-648 in Part 2.

Participant milestones

Measure	Part 1 Cohort 1: TAK-648 0.35 mg Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 1: TAK-648 0.05 mg Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 2: TAK-648 0.15 mg Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 3: TAK-648 0.35 mg Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Part 1 STARTED	6	6	4	0	0	0	0	0
Part 1 COMPLETED	6	6	4	0	0	0	0	0
Part 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	6	6	6	6	8
Part 2 COMPLETED	0	0	0	6	6	6	5	7
Part 2 NOT COMPLETED	0	0	0	0	0	0	1	1

Reasons for withdrawal

Measure	Part 1 Cohort 1: TAK-648 0.35 mg Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 1: TAK-648 0.05 mg Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 2: TAK-648 0.15 mg Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 3: TAK-648 0.35 mg Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Part 2 Voluntary Withdrawal	0	0	0	0	0	0	1	0
Part 2 Other Reason Not Specified	0	0	0	0	0	0	0	1

Baseline Characteristics

TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 1: TAK-648 0.05 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 2: TAK-648 0.15 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 3: TAK-648 0.35 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 Participants Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Total n=48 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	37.3 years STANDARD_DEVIATION 9.63 • n=4 Participants	36.0 years STANDARD_DEVIATION 10.45 • n=21 Participants	32.2 years STANDARD_DEVIATION 12.48 • n=10 Participants	33.0 years STANDARD_DEVIATION 4.10 • n=115 Participants	35.3 years STANDARD_DEVIATION 9.82 • n=6 Participants	34.8 years STANDARD_DEVIATION 9.26 • n=6 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=6 Participants	NA Participants n=6 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=6 Participants	NA Participants n=6 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 participants 4.09 • n=5 Participants	5 participants 9.95 • n=7 Participants	4 participants 8.70 • n=5 Participants	NA participants NA • n=4 Participants	NA participants NA • n=21 Participants	NA participants NA • n=10 Participants	NA participants NA • n=115 Participants	NA participants NA • n=6 Participants	NA participants n=6 Participants
Race/Ethnicity, Customized Non-Hispanic and Latino	NA participants 5.082 • n=5 Participants	NA participants 17.359 • n=7 Participants	NA participants 17.068 • n=5 Participants	6 participants NA • n=4 Participants	6 participants NA • n=21 Participants	6 participants NA • n=10 Participants	6 participants NA • n=115 Participants	8 participants NA • n=6 Participants	NA participants n=6 Participants
Race/Ethnicity, Customized White	6 participants 2.176 • n=5 Participants	6 participants 4.599 • n=7 Participants	4 participants 4.146 • n=5 Participants	NA participants NA • n=4 Participants	NA participants NA • n=21 Participants	NA participants NA • n=10 Participants	NA participants NA • n=115 Participants	NA participants NA • n=6 Participants	NA participants n=6 Participants
Race/Ethnicity, Customized Asian	NA participants 534.56 • n=5 Participants	NA participants 709.93 • n=7 Participants	NA participants 645.98 • n=5 Participants	6 participants NA • n=4 Participants	6 participants NA • n=21 Participants	6 participants NA • n=10 Participants	6 participants NA • n=115 Participants	8 participants NA • n=6 Participants	NA participants n=6 Participants
Region of Enrollment United States	NA participants NA • n=5 Participants	NA participants NA • n=7 Participants	NA participants NA • n=5 Participants	6 participants 9.63 • n=4 Participants	6 participants 10.45 • n=21 Participants	6 participants 12.48 • n=10 Participants	6 participants 4.10 • n=115 Participants	8 participants 9.82 • n=6 Participants	NA participants n=6 Participants
Height	NA cm STANDARD_DEVIATION NA • n=5 Participants	NA cm STANDARD_DEVIATION NA • n=7 Participants	NA cm STANDARD_DEVIATION NA • n=5 Participants	172.7 cm STANDARD_DEVIATION 5.32 • n=4 Participants	169.0 cm STANDARD_DEVIATION 13.02 • n=21 Participants	164.5 cm STANDARD_DEVIATION 6.57 • n=10 Participants	166.3 cm STANDARD_DEVIATION 8.19 • n=115 Participants	164.9 cm STANDARD_DEVIATION 8.43 • n=6 Participants	167.3 cm STANDARD_DEVIATION 8.66 • n=6 Participants
Weight	NA kg STANDARD_DEVIATION NA • n=5 Participants	NA kg STANDARD_DEVIATION NA • n=7 Participants	NA kg STANDARD_DEVIATION NA • n=5 Participants	67.52 kg STANDARD_DEVIATION 9.055 • n=4 Participants	65.40 kg STANDARD_DEVIATION 12.236 • n=21 Participants	57.82 kg STANDARD_DEVIATION 6.421 • n=10 Participants	64.47 kg STANDARD_DEVIATION 11.585 • n=115 Participants	58.40 kg STANDARD_DEVIATION 10.206 • n=6 Participants	62.45 kg STANDARD_DEVIATION 10.248 • n=6 Participants
Body Mass Index (BMI)	NA kg/m^2 STANDARD_DEVIATION NA • n=5 Participants	NA kg/m^2 STANDARD_DEVIATION NA • n=7 Participants	NA kg/m^2 STANDARD_DEVIATION NA • n=5 Participants	22.58 kg/m^2 STANDARD_DEVIATION 2.207 • n=4 Participants	22.70 kg/m^2 STANDARD_DEVIATION 1.531 • n=21 Participants	21.33 kg/m^2 STANDARD_DEVIATION 1.983 • n=10 Participants	23.13 kg/m^2 STANDARD_DEVIATION 2.234 • n=115 Participants	21.34 kg/m^2 STANDARD_DEVIATION 2.215 • n=6 Participants	22.16 kg/m^2 STANDARD_DEVIATION 2.072 • n=6 Participants
Metformin Dose	1425.0 mg STANDARD_DEVIATION 534.56 • n=5 Participants	1400.0 mg STANDARD_DEVIATION 709.93 • n=7 Participants	1812.5 mg STANDARD_DEVIATION 645.98 • n=5 Participants	NA mg STANDARD_DEVIATION NA • n=4 Participants	NA mg STANDARD_DEVIATION NA • n=21 Participants	NA mg STANDARD_DEVIATION NA • n=10 Participants	NA mg STANDARD_DEVIATION NA • n=115 Participants	NA mg STANDARD_DEVIATION NA • n=6 Participants	1512.5 mg STANDARD_DEVIATION 615.49 • n=6 Participants
Duration of Type 2 Diabetes Mellitus (T2DM)	12.7 years STANDARD_DEVIATION 5.68 • n=5 Participants	9.3 years STANDARD_DEVIATION 5.16 • n=7 Participants	9.0 years STANDARD_DEVIATION 3.37 • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants	NA years STANDARD_DEVIATION NA • n=115 Participants	NA years STANDARD_DEVIATION NA • n=6 Participants	10.5 years STANDARD_DEVIATION 4.99 • n=6 Participants

PRIMARY outcome

Timeframe: Up to Day 34

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of 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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1	83.3 percentage of participants	33.3 percentage of participants	100.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to Day 26

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of 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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 Participants Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2	100.0 percentage of participants	33.3 percentage of participants	66.7 percentage of participants	83.3 percentage of participants	37.5 percentage of participants

PRIMARY outcome

Timeframe: Up to Day 20

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to Day 13

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 Participants Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Up to Day 20

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1 < Lower Criteria	0 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	—	—
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1 > Upper Criteria	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to Day 13

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 Participants Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2 < Lower Criteria	50.0 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	37.5 percentage of participants
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2 > Upper Criteria	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Up to Day 20

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to Day 13

Population: Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.

Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 Participants Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Cmax: Maximum Plasma Concentration for TAK-648 for Part 1 Day 1	6.342 ng/mL Standard Deviation 1.3552	16.150 ng/mL Standard Deviation 3.2073	—	—	—
Cmax: Maximum Plasma Concentration for TAK-648 for Part 1 Day 17	7.950 ng/mL Standard Deviation 2.3885	16.283 ng/mL Standard Deviation 4.6521	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Cmax: Maximum Plasma Concentration for TAK-648 for Part 2 Day 1	0.764 mg/mL Standard Deviation 0.2436	1.955 mg/mL Standard Deviation 0.3455	5.925 mg/mL Standard Deviation 1.9491	10.080 mg/mL Standard Deviation 5.2665	—
Cmax: Maximum Plasma Concentration for TAK-648 for Part 2 Day 10	0.670 mg/mL Standard Deviation 0.2054	2.355 mg/mL Standard Deviation 0.1499	6.430 mg/mL Standard Deviation 2.5774	9.612 mg/mL Standard Deviation 3.5611	—

SECONDARY outcome

Timeframe: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1 Day 1	0.500 hours (hr) Interval 0.5 to 0.5	1.000 hours (hr) Interval 0.5 to 1.5	—	—	—
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1 Day 17	0.500 hours (hr) Interval 0.5 to 1.0	0.710 hours (hr) Interval 0.5 to 2.0	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2 Day 1	1.000 hr Interval 0.5 to 2.0	1.000 hr Interval 0.5 to 1.5	1.000 hr Interval 0.5 to 1.0	1.000 hr Interval 0.5 to 1.5	—
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2 Day 10	1.500 hr Interval 1.0 to 2.0	0.750 hr Interval 0.5 to 1.5	1.000 hr Interval 0.5 to 1.5	1.000 hr Interval 0.5 to 4.0	—

SECONDARY outcome

Timeframe: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1 Day 1	31.676 ng*hr/mL Standard Deviation 10.2111	88.168 ng*hr/mL Standard Deviation 28.2484	—	—	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1 Day 17	43.908 ng*hr/mL Standard Deviation 18.4433	107.492 ng*hr/mL Standard Deviation 39.6210	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2 Day 1	5.018 ng*hr/mL Standard Deviation 1.3681	14.861 ng*hr/mL Standard Deviation 3.0267	38.878 ng*hr/mL Standard Deviation 12.7876	63.376 ng*hr/mL Standard Deviation 19.6130	—
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2 Day 10	5.355 ng*hr/mL Standard Deviation 1.5083	19.274 ng*hr/mL Standard Deviation 3.5884	38.123 ng*hr/mL Standard Deviation 14.0762	75.183 ng*hr/mL Standard Deviation 35.8763	—

SECONDARY outcome

Timeframe: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1 Day 1	31.973 ng*hr/mL Standard Deviation 10.3893	89.043 ng*hr/mL Standard Deviation 29.0630	—	—	—
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1 Day 17	46.827 ng*hr/mL Standard Deviation 21.8685	110.882 ng*hr/mL Standard Deviation 41.8979	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2 Day 1	5.147 ng*hr/mL Standard Deviation 1.3861	15.078 ng*hr/mL Standard Deviation 3.0768	39.160 ng*hr/mL Standard Deviation 12.8099	64.694 ng*hr/mL Standard Deviation 20.2316	—
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2 Day 10	5.538 ng*hr/mL Standard Deviation 1.5656	19.922 ng*hr/mL Standard Deviation 3.8508	39.103 ng*hr/mL Standard Deviation 14.5245	77.369 ng*hr/mL Standard Deviation 36.7414	—

SECONDARY outcome

Timeframe: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1 Day 1	30.209 ng*hr/mL Standard Deviation 9.0944	82.148 ng*hr/mL Standard Deviation 21.9186	—	—	—
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1 Day 17	39.283 ng*hr/mL Standard Deviation 15.7882	95.028 ng*hr/mL Standard Deviation 28.9547	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)

Population: The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.

Outcome measures

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 Participants Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=6 Participants Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 Participants Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2 Day 1	4.833 ng*hr/mL Standard Deviation 1.2018	13.902 ng*hr/mL Standard Deviation 2.5432	36.570 ng*hr/mL Standard Deviation 11.8662	59.507 ng*hr/mL Standard Deviation 18.5291	—
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2 Day 10	5.036 ng*hr/mL Standard Deviation 1.3032	17.215 ng*hr/mL Standard Deviation 2.8909	34.661 ng*hr/mL Standard Deviation 13.0489	67.785 ng*hr/mL Standard Deviation 28.2776	—

Adverse Events

Part 1 Cohort 1: TAK-648 0.35 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1 Cohort 2: TAK-648 0.80 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Placebo Cohort 1-2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2 Cohort 1: TAK-648 0.05 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2 Cohort 2: TAK-648 0.15 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 Cohort 3: TAK-648 0.35 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2 Cohort 4: TAK-648 0.80 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: Placebo Cohort 1-4

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1 Cohort 1: TAK-648 0.35 mg n=6 participants at risk Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1 Cohort 2: TAK-648 0.80 mg n=6 participants at risk Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 1: Placebo Cohort 1-2 n=4 participants at risk Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).	Part 2 Cohort 1: TAK-648 0.05 mg n=6 participants at risk Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 2: TAK-648 0.15 mg n=6 participants at risk Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 3: TAK-648 0.35 mg n=6 participants at risk Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2 Cohort 4: TAK-648 0.80 mg n=6 participants at risk Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).	Part 2: Placebo Cohort 1-4 n=8 participants at risk Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
Cardiac disorders Bundle branch block left	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Tachycardia	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 2/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site dermatitis	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site erythema	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site irritation	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site pruritus	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Application site reaction	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Body tinea	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tooth abscess	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood pressure orthostatic decreased	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Presyncope	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	66.7% 4/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 1/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.5% 1/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/4 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/8 • AEs were routinely collected from the time of first study drug administration until Follow-up Visit on Day 34 (±2) days (Part 1), and Day 26 (±2) days (Part 2). At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director Clinical Science

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