Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers (NCT NCT02413255)

NCT ID: NCT02413255

Last Updated: 2019-01-07

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 TEAE is defined as an adverse event that occurred or worsened after receiving study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 120 participants
• Primary outcome timeframe: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1
• Results posted on: 2019-01-07

Participant Flow

Participants took part in the study at 1 investigative sites in the United States from 18 March 2015 to 04 May 2017.

Healthy volunteers were enrolled to receive TAK-020 oral solution Single Rising Doses (SRD) [0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70, 105 milligrams (mgs)] or placebo in Part 1 or Multiple Rising Doses (MRD) [3.75, 5.75, 13, 25, 45, 60 mgs] or Placebo in Part 2.

Participant milestones

Measure	Part 1 Cohort 1-9: Placebo TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.	Part 2 Cohort 1-6: Placebo TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.	Part 2 Cohort 1: TAK-020 3.75 mg TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.	Part 2 Cohort 2: TAK-020 5.75 mg TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.	Part 2 Cohort 3: TAK-020 13 mg TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.	Part 2 Cohort 4: TAK-020 25 mg TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.	Part 2 Cohort 5: TAK-020 45 mg TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.	Part 2 Cohort 6: TAK-020 60 mg TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
Overall Study STARTED	18	6	6	6	6	6	6	6	6	6	12	6	6	6	6	6	6
Overall Study COMPLETED	18	6	6	6	6	6	6	6	6	6	12	6	6	6	5	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0

Reasons for withdrawal

Measure	Part 1 Cohort 1-9: Placebo TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.	Part 2 Cohort 1-6: Placebo TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.	Part 2 Cohort 1: TAK-020 3.75 mg TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.	Part 2 Cohort 2: TAK-020 5.75 mg TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.	Part 2 Cohort 3: TAK-020 13 mg TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.	Part 2 Cohort 4: TAK-020 25 mg TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.	Part 2 Cohort 5: TAK-020 45 mg TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.	Part 2 Cohort 6: TAK-020 60 mg TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
Overall Study Voluntary Withdrawal	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Body Mass Index = weight (kg)/[height (m)^2]

Baseline characteristics by cohort

Measure	Part 1 Cohort 1-9: Placebo n=18 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 Participants TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.	Part 2 Cohort 1-6: Placebo n=12 Participants TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.	Part 2 Cohort 1: TAK-020 3.75 mg n=6 Participants TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.	Part 2 Cohort 2: TAK-020 5.75 mg n=6 Participants TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.	Part 2 Cohort 3: TAK-020 13 mg n=6 Participants TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.	Part 2 Cohort 4: TAK-020 25 mg n=6 Participants TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.	Part 2 Cohort 5: TAK-020 45 mg n=6 Participants TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.	Part 2 Cohort 6: TAK-020 60 mg n=6 Participants TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.	Total n=120 Participants Total of all reporting groups
Caffeine Consumption No	17 Participants n=18 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	9 Participants n=12 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	97 Participants n=120 Participants
Age, Continuous	35.1 years STANDARD_DEVIATION 10.93 • n=18 Participants	46.0 years STANDARD_DEVIATION 10.06 • n=6 Participants	38.0 years STANDARD_DEVIATION 11.15 • n=6 Participants	38.0 years STANDARD_DEVIATION 11.82 • n=6 Participants	29.0 years STANDARD_DEVIATION 11.82 • n=6 Participants	35.8 years STANDARD_DEVIATION 11.44 • n=6 Participants	38.2 years STANDARD_DEVIATION 12.56 • n=6 Participants	33.7 years STANDARD_DEVIATION 8.24 • n=6 Participants	34.3 years STANDARD_DEVIATION 12.61 • n=6 Participants	34.8 years STANDARD_DEVIATION 7.81 • n=6 Participants	37.0 years STANDARD_DEVIATION 8.83 • n=12 Participants	34.2 years STANDARD_DEVIATION 8.59 • n=6 Participants	43.2 years STANDARD_DEVIATION 9.02 • n=6 Participants	29.3 years STANDARD_DEVIATION 9.40 • n=6 Participants	35.7 years STANDARD_DEVIATION 9.40 • n=6 Participants	36.2 years STANDARD_DEVIATION 11.96 • n=6 Participants	34.8 years STANDARD_DEVIATION 10.01 • n=6 Participants	36.0 years STANDARD_DEVIATION 10.38 • n=120 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	5 Participants n=12 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	40 Participants n=120 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	7 Participants n=12 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	80 Participants n=120 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=12 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	25 Participants n=120 Participants
Race/Ethnicity, Customized Non-Hispanic and Latino	16 Participants n=18 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	10 Participants n=12 Participants	5 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	95 Participants n=120 Participants
Race/Ethnicity, Customized Asian	1 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	6 Participants n=120 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=18 Participants	4 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	7 Participants n=12 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	38 Participants n=120 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=120 Participants
Race/Ethnicity, Customized White	8 Participants n=18 Participants	2 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=12 Participants	2 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	67 Participants n=120 Participants
Race/Ethnicity, Customized Multiracial	2 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	6 Participants n=120 Participants
Region of Enrollment United States	18 Participants n=18 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	120 Participants n=120 Participants
Body Mass Index (BMI)	26.18 kg/m^2 STANDARD_DEVIATION 3.741 • n=18 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	27.04 kg/m^2 STANDARD_DEVIATION 3.823 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	27.24 kg/m^2 STANDARD_DEVIATION 3.308 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.77 kg/m^2 STANDARD_DEVIATION 4.359 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	23.91 kg/m^2 STANDARD_DEVIATION 3.221 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	23.23 kg/m^2 STANDARD_DEVIATION 2.549 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.87 kg/m^2 STANDARD_DEVIATION 3.332 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	23.98 kg/m^2 STANDARD_DEVIATION 1.408 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	24.47 kg/m^2 STANDARD_DEVIATION 2.263 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	26.89 kg/m^2 STANDARD_DEVIATION 1.468 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.36 kg/m^2 STANDARD_DEVIATION 2.645 • n=12 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	27.26 kg/m^2 STANDARD_DEVIATION 3.516 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	24.97 kg/m^2 STANDARD_DEVIATION 4.563 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.83 kg/m^2 STANDARD_DEVIATION 2.707 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	28.64 kg/m^2 STANDARD_DEVIATION 2.935 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.07 kg/m^2 STANDARD_DEVIATION 2.124 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	27.05 kg/m^2 STANDARD_DEVIATION 2.851 • n=6 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]	25.82 kg/m^2 STANDARD_DEVIATION 3.223 • n=120 Participants • Body Mass Index = weight (kg)/\[height (m)\^2\]
Smoking History Never Smoked	16 Participants n=18 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	11 Participants n=12 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	106 Participants n=120 Participants
Smoking History Ex-smoker	2 Participants n=18 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=12 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	14 Participants n=120 Participants
Alcohol History Never drank	14 Participants n=18 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	9 Participants n=12 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	96 Participants n=120 Participants
Alcohol History Current drinker	4 Participants n=18 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=12 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	22 Participants n=120 Participants
Alcohol History Ex- drinker	0 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=120 Participants
Alcohol Participant Consumed	4 Participants n=4 Participants • Assessment was performed on participants who were current drinkers.	1 Participants n=1 Participants • Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	2 Participants n=2 Participants • Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	0 Participants n=3 Participants • Assessment was performed on participants who were current drinkers.	0 Participants n=3 Participants • Assessment was performed on participants who were current drinkers.	0 Participants n=2 Participants • Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	2 Participants n=2 Participants • Assessment was performed on participants who were current drinkers.	2 Participants n=2 Participants • Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	2 Participants n=2 Participants • Assessment was performed on participants who were current drinkers.	1 Participants n=1 Participants • Assessment was performed on participants who were current drinkers.	0 Participants Assessment was performed on participants who were current drinkers.	14 Participants n=22 Participants • Assessment was performed on participants who were current drinkers.
Caffeine Consumption Yes	1 Participants n=18 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=12 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	23 Participants n=120 Participants
Xanthine Consumption Yes	1 Participants n=18 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=12 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	21 Participants n=120 Participants
Xanthine Consumption No	17 Participants n=18 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	9 Participants n=12 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	99 Participants n=120 Participants
Female Reproductive Status Postmenopausal	2 Participants n=18 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	7 Participants n=120 Participants
Female Reproductive Status Surgically Sterile	0 Participants n=18 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=12 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=120 Participants
Female Reproductive Status Female of Childbearing Potential	9 Participants n=18 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=12 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	29 Participants n=120 Participants
Female Reproductive Status Not Applicable (Participant was Male)	7 Participants n=18 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	7 Participants n=12 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	80 Participants n=120 Participants

PRIMARY outcome

Timeframe: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1

Population: Safety Analysis Set was comprised of all participants who received study drug.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=18 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 Participants TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD)	11.1 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	50 percentage of participants	16.7 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 to Day 14 of Part 1

Population: Safety Analysis Set was comprised of all participants who received study drug.

Safety laboratory tests includes hematology, serum chemistries, and urinalysis.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=18 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 Participants TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Blood Urea Nitrogen (BUN) >10.7 mmol/L	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Hematology	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Sodium <130 mmol/L	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Sodium >150 mmol/L	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Bilirubin Total >34.2 umol/L	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD) Triglycerides >2.5*ULN	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 to Day 14 of Part 1

Population: Safety Analysis Set was comprised of all participants who received study drug.

Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=18 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 Participants TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Diastolic Blood Pressure <50 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Pulse <50 bpm	11.1 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	50 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Pulse >120 bpm	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Systolic Blood Pressure <85 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Systolic Blood Pressure >180 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Diastolic Blood Pressure >110 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Body Temperature <35.6 C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD) Body Temperature >37.7 C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 to Day 14 in Part 1

Population: Safety Analysis Set was comprised of all participants who received study drug.

A standard 12-lead ECG was performed. Change from baseline=CFB.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=18 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 Participants TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QTcF Interval (ms) <= 300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QRS Interval (ms) <= 80	38.9 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	66.7 percentage of participants	83.3 percentage of participants	33.3 percentage of participants	83.3 percentage of participants	0 percentage of participants	16.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QRS Interval (ms) >= 180	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) Heart Rate (beats/min) <50	44.4 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) Heart Rate (beats/min) >120	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) PR Interval (msec[ms]) <=80	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) PR Interval (ms) >= 200	5.6 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	0 percentage of participants	33.3 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QT Interval (ms) <=300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QT Interval (ms) >=460	5.6 percentage of participants	0 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QTcB Interval (ms) <=300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QTcB Interval (ms) ≥500/ ≥30 CFB and ≥450	11.1 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD) QTcF Interval (ms) ≥500/≥30 CFB and >= 450	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2

Population: Safety Analysis Set was comprised of all participants who received study drug.

An 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 TEAE is defined as an adverse event that occurred or worsened after receiving study drug.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=12 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD)	41.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 17 in Part 2

Population: Safety Analysis Set included all participants who received study drug.

Safety laboratory tests include hematology, and serum chemistries.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=12 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) Hematology	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) Creatine Kinase >5*ULN (U/L)	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD) Lipase >3*ULN (U/L)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 17 in Part 2

Population: Safety Analysis Set included all participants who received study drug.

Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=12 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Pulse <50 bpm	8.3 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Pulse >120 bpm	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Systolic Blood Pressure <85 mm Hg	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Systolic Blood Pressure >180 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Diastolic Blood Pressure <50 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Diastolic Blood Pressure >110 mm Hg	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Body Temperature <35.6 C	33.3 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD) Body Temperature >37.7 C	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: From Day 1 to Day 17 in Part 2

Population: Safety Analysis Set included all participants who received study drug.

A standard 12-lead ECG was performed.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=12 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QTcF Interval (ms) ≥500/≥30 CFB and >= 450	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QRS Interval (msec) <=80	50.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) Heart Rate (beats/min) <50	16.7 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants	50.0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) Heart Rate (beats/min) >120	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) PR Interval (msec) <=80	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) PR Interval (msec) >=200	16.7 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QT Interval (msec) <=300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QT Interval (msec) >=460	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	16.7 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QTcB Interval (msec) <=300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QTcB Interval (ms) ≥500/≥ 30 CFB and ≥450	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QTcF Interval (msec) <=300	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD) QRS Interval (msec) >=180	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD)	0.4631 ng/mL Geometric Coefficient of Variation 36.3	1.5529 ng/mL Geometric Coefficient of Variation 25.2	13.5475 ng/mL Geometric Coefficient of Variation 40.7	24.2013 ng/mL Geometric Coefficient of Variation 29.5	42.8329 ng/mL Geometric Coefficient of Variation 43.3	105.7708 ng/mL Geometric Coefficient of Variation 33.3	155.6549 ng/mL Geometric Coefficient of Variation 31.8	446.1922 ng/mL Geometric Coefficient of Variation 50.9	345.4612 ng/mL Geometric Coefficient of Variation 51.6	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) Day 1	16.4167 ng/mL Geometric Coefficient of Variation 46.7	40.3204 ng/mL Geometric Coefficient of Variation 14.4	64.7590 ng/mL Geometric Coefficient of Variation 73.3	161.9015 ng/mL Geometric Coefficient of Variation 47.1	300.8684 ng/mL Geometric Coefficient of Variation 33.3	423.8189 ng/mL Geometric Coefficient of Variation 46.9	—	—	—	—
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD) Day 9	17.6976 ng/mL Geometric Coefficient of Variation 34.2	39.6336 ng/mL Geometric Coefficient of Variation 17.7	63.6636 ng/mL Geometric Coefficient of Variation 34.5	160.6945 ng/mL Geometric Coefficient of Variation 33.0	279.6237 ng/mL Geometric Coefficient of Variation 34.1	433.4214 ng/mL Geometric Coefficient of Variation 43.7	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD)	0.750 hr Interval 0.5 to 0.77	0.700 hr Interval 0.48 to 2.02	0.745 hr Interval 0.52 to 1.0	0.825 hr Interval 0.48 to 1.97	0.780 hr Interval 0.67 to 1.05	1.010 hr Interval 0.58 to 2.0	0.630 hr Interval 0.5 to 1.02	0.725 hr Interval 0.5 to 1.0	0.750 hr Interval 0.5 to 2.15	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) Day 1	0.750 hr Interval 0.5 to 0.98	0.750 hr Interval 0.52 to 1.08	0.750 hr Interval 0.5 to 2.0	0.750 hr Interval 0.5 to 2.0	0.500 hr Interval 0.5 to 1.02	0.640 hr Interval 0.5 to 1.07	—	—	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD) Day 9	0.750 hr Interval 0.5 to 1.07	1.000 hr Interval 0.75 to 1.0	0.750 hr Interval 0.5 to 1.0	0.750 hr Interval 0.5 to 0.75	0.750 hr Interval 0.5 to 1.0	0.875 hr Interval 0.47 to 1.98	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD)	0.7599 ng*hr/mL Geometric Coefficient of Variation 45.6	3.6691 ng*hr/mL Geometric Coefficient of Variation 28.2	29.7502 ng*hr/mL Geometric Coefficient of Variation 48.1	63.1772 ng*hr/mL Geometric Coefficient of Variation 31.3	98.8228 ng*hr/mL Geometric Coefficient of Variation 34.6	272.3381 ng*hr/mL Geometric Coefficient of Variation 39.5	372.5881 ng*hr/mL Geometric Coefficient of Variation 35.2	1009.0958 ng*hr/mL Geometric Coefficient of Variation 32.3	875.0011 ng*hr/mL Geometric Coefficient of Variation 15.9	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) Day 1	34.6177 ng*hr/mL Geometric Coefficient of Variation 50.4	86.4177 ng*hr/mL Geometric Coefficient of Variation 18.5	148.6319 ng*hr/mL Geometric Coefficient of Variation 64.8	389.8000 ng*hr/mL Geometric Coefficient of Variation 43.0	576.1987 ng*hr/mL Geometric Coefficient of Variation 31.5	808.3223 ng*hr/mL Geometric Coefficient of Variation 39.1	—	—	—	—
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD) Day 9	39.0653 ng*hr/mL Geometric Coefficient of Variation 43.9	100.2960 ng*hr/mL Geometric Coefficient of Variation 21.2	147.1828 ng*hr/mL Geometric Coefficient of Variation 47.8	400.5548 ng*hr/mL Geometric Coefficient of Variation 27.6	648.9853 ng*hr/mL Geometric Coefficient of Variation 25.3	1011.2702 ng*hr/mL Geometric Coefficient of Variation 44.9	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD)	7.5994 ng*hr/mL/mg Geometric Coefficient of Variation 45.6	7.3382 ng*hr/mL/mg Geometric Coefficient of Variation 28.2	11.9001 ng*hr/mL/mg Geometric Coefficient of Variation 48.1	14.3584 ng*hr/mL/mg Geometric Coefficient of Variation 31.3	11.2299 ng*hr/mL/mg Geometric Coefficient of Variation 34.6	15.5622 ng*hr/mL/mg Geometric Coefficient of Variation 39.5	10.6454 ng*hr/mL/mg Geometric Coefficient of Variation 35.2	14.4157 ng*hr/mL/mg Geometric Coefficient of Variation 32.3	8.3333 ng*hr/mL/mg Geometric Coefficient of Variation 15.9	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) Day 1	9.2314 ng*hr/mL/mg Geometric Coefficient of Variation 50.4	15.0292 ng*hr/mL/mg Geometric Coefficient of Variation 18.5	11.4332 ng*hr/mL/mg Geometric Coefficient of Variation 64.8	15.5920 ng*hr/mL/mg Geometric Coefficient of Variation 43.0	12.8044 ng*hr/mL/mg Geometric Coefficient of Variation 31.5	13.4720 ng*hr/mL/mg Geometric Coefficient of Variation 39.1	—	—	—	—
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD) Day 9	10.4174 ng*hr/mL/mg Geometric Coefficient of Variation 43.9	17.4428 ng*hr/mL/mg Geometric Coefficient of Variation 21.2	11.3218 ng*hr/mL/mg Geometric Coefficient of Variation 47.8	16.0222 ng*hr/mL/mg Geometric Coefficient of Variation 27.6	14.4219 ng*hr/mL/mg Geometric Coefficient of Variation 25.3	16.8545 ng*hr/mL/mg Geometric Coefficient of Variation 44.9	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD)	0.6674 ng*hr/mL Geometric Coefficient of Variation 50.3	3.5250 ng*hr/mL Geometric Coefficient of Variation 30.3	29.4206 ng*hr/mL Geometric Coefficient of Variation 48.1	62.4593 ng*hr/mL Geometric Coefficient of Variation 31.9	98.6610 ng*hr/mL Geometric Coefficient of Variation 34.4	273.0083 ng*hr/mL Geometric Coefficient of Variation 40.0	378.3179 ng*hr/mL Geometric Coefficient of Variation 35.5	1024.5599 ng*hr/mL Geometric Coefficient of Variation 32.5	903.9858 ng*hr/mL Geometric Coefficient of Variation 14.6	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD)	34.1425 ng*hr/mL Geometric Coefficient of Variation 50.2	85.7708 ng*hr/mL Geometric Coefficient of Variation 18.3	148.6319 ng*hr/mL Geometric Coefficient of Variation 64.8	391.5478 ng*hr/mL Geometric Coefficient of Variation 43.2	583.7178 ng*hr/mL Geometric Coefficient of Variation 32.2	823.3525 ng*hr/mL Geometric Coefficient of Variation 39.0	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)	1.3733 ng*hr/mL Geometric Coefficient of Variation 32.1	3.8341 ng*hr/mL Geometric Coefficient of Variation 26.8	29.9808 ng*hr/mL Geometric Coefficient of Variation 47.4	69.3298 ng*hr/mL Geometric Coefficient of Variation 24.2	100.2928 ng*hr/mL Geometric Coefficient of Variation 34.3	275.1708 ng*hr/mL Geometric Coefficient of Variation 39.6	380.2423 ng*hr/mL Geometric Coefficient of Variation 35.2	1030.7508 ng*hr/mL Geometric Coefficient of Variation 32.3	907.7704 ng*hr/mL Geometric Coefficient of Variation 14.5	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)	34.8469 ng*hr/mL Geometric Coefficient of Variation 49.8	86.7892 ng*hr/mL Geometric Coefficient of Variation 18.1	149.9419 ng*hr/mL Geometric Coefficient of Variation 64.5	393.8737 ng*hr/mL Geometric Coefficient of Variation 43.2	587.4204 ng*hr/mL Geometric Coefficient of Variation 31.8	825.6238 ng*hr/mL Geometric Coefficient of Variation 38.9	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD)	1.1285 ratio Geometric Coefficient of Variation 21.9	1.1606 ratio Geometric Coefficient of Variation 8.9	0.9903 ratio Geometric Coefficient of Variation 18.7	1.0628 ratio Geometric Coefficient of Variation 23.3	1.1263 ratio Geometric Coefficient of Variation 10.7	1.2511 ratio Geometric Coefficient of Variation 15.6	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD)	1.0780 ratio Geometric Coefficient of Variation 22.9	0.9830 ratio Geometric Coefficient of Variation 10.5	0.9831 ratio Geometric Coefficient of Variation 39.4	0.9379 ratio Geometric Coefficient of Variation 29.2	0.9294 ratio Geometric Coefficient of Variation 16.3	1.0227 ratio Geometric Coefficient of Variation 29.5	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD)	4.6312 ng/mL/mg Geometric Coefficient of Variation 36.3	3.1058 ng/mL/mg Geometric Coefficient of Variation 25.2	5.4190 ng/mL/mg Geometric Coefficient of Variation 40.7	5.5003 ng/mL/mg Geometric Coefficient of Variation 29.5	4.8674 ng/mL/mg Geometric Coefficient of Variation 43.3	6.0440 ng/mL/mg Geometric Coefficient of Variation 33.3	4.4473 ng/mL/mg Geometric Coefficient of Variation 31.8	6.3742 ng/mL/mg Geometric Coefficient of Variation 50.9	3.2901 ng/mL/mg Geometric Coefficient of Variation 51.6	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) Day 1	4.3778 ng/mL/mg Geometric Coefficient of Variation 46.7	7.0123 ng/mL/mg Geometric Coefficient of Variation 14.4	4.9815 ng/mL/mg Geometric Coefficient of Variation 73.3	6.4761 ng/mL/mg Geometric Coefficient of Variation 47.1	6.6860 ng/mL/mg Geometric Coefficient of Variation 33.3	7.0636 ng/mL/mg Geometric Coefficient of Variation 46.9	—	—	—	—
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD) Day 9	4.7194 ng/mL/mg Geometric Coefficient of Variation 34.2	6.8928 ng/mL/mg Geometric Coefficient of Variation 17.7	4.8972 ng/mL/mg Geometric Coefficient of Variation 34.5	6.4278 ng/mL/mg Geometric Coefficient of Variation 33.0	6.2139 ng/mL/mg Geometric Coefficient of Variation 34.1	7.2237 ng/mL/mg Geometric Coefficient of Variation 43.7	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD)	1.1251 hr Standard Deviation 0.16347	1.5323 hr Standard Deviation 0.28359	2.2093 hr Standard Deviation 0.41162	3.0159 hr Standard Deviation 0.70963	4.8384 hr Standard Deviation 1.06916	4.2946 hr Standard Deviation 1.18227	6.0601 hr Standard Deviation 1.55255	6.1098 hr Standard Deviation 1.65014	9.0275 hr Standard Deviation 4.78526	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) Day 1	2.5948 hr Standard Deviation 0.42162	3.3397 hr Standard Deviation 0.96341	4.1895 hr Standard Deviation 0.40518	4.8507 hr Standard Deviation 2.21078	6.0124 hr Standard Deviation 2.30297	6.2971 hr Standard Deviation 1.82711	—	—	—	—
T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD) Day 9	2.1537 hr Standard Deviation 0.42833	3.2089 hr Standard Deviation 0.77467	4.1335 hr Standard Deviation 0.51741	3.7934 hr Standard Deviation 0.70657	5.1273 hr Standard Deviation 1.58301	5.4635 hr Standard Deviation 1.47268	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD)	0.6226 1/hr Standard Deviation 0.09046	0.4659 1/hr Standard Deviation 0.08893	0.3223 1/hr Standard Deviation 0.05573	0.2402 1/hr Standard Deviation 0.05603	0.1496 1/hr Standard Deviation 0.03468	0.1745 1/hr Standard Deviation 0.05957	0.1202 1/hr Standard Deviation 0.02831	0.1216 1/hr Standard Deviation 0.03677	0.1004 1/hr Standard Deviation 0.06068	—

SECONDARY outcome

Timeframe: From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) Day 1	0.2732 1/hr Standard Deviation 0.04550	0.2231 1/hr Standard Deviation 0.06562	0.1667 1/hr Standard Deviation 0.01608	0.1655 1/hr Standard Deviation 0.05994	0.1263 1/hr Standard Deviation 0.03599	0.1216 1/hr Standard Deviation 0.04880	—	—	—	—
Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD) Day 9	0.3325 1/hr Standard Deviation 0.07185	0.2264 1/hr Standard Deviation 0.05325	0.1699 1/hr Standard Deviation 0.02117	0.1880 1/hr Standard Deviation 0.03581	0.1471 1/hr Standard Deviation 0.04752	0.1363 1/hr Standard Deviation 0.04310	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD)	0.0000 hr Interval 0.0 to 0.25	0.0000 hr Interval 0.0 to 0.22	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) Day 1	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	—	—	—	—
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD) Day 9	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	0.0000 hr Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

CL/F was calculated as dose/AUC∞.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD)	74.6058 L/h Standard Deviation 22.96089	134.3327 L/h Standard Deviation 36.96594	90.8722 L/h Standard Deviation 42.30328	64.9449 L/h Standard Deviation 15.91608	92.1842 L/h Standard Deviation 34.02451	67.4975 L/h Standard Deviation 25.25161	96.6058 L/h Standard Deviation 32.53095	70.7695 L/h Standard Deviation 22.35098	116.6389 L/h Standard Deviation 16.07341	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

CL/F was calculated as dose/AUCτ.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) Day 1	118.3171 L/h Standard Deviation 58.62331	67.1355 L/h Standard Deviation 11.81065	100.6915 L/h Standard Deviation 62.33954	68.2909 L/h Standard Deviation 29.74598	79.5377 L/h Standard Deviation 22.34558	76.9650 L/h Standard Deviation 28.27771	—	—	—	—
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD) Day 9	103.2882 L/h Standard Deviation 42.85829	58.3884 L/h Standard Deviation 12.20159	96.5521 L/h Standard Deviation 46.88638	64.1696 L/h Standard Deviation 16.00068	71.1027 L/h Standard Deviation 16.99648	64.2873 L/h Standard Deviation 29.63651	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Vz/F was calculated as (CL/F)/λz.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)	118.3923 L Standard Deviation 19.67518	292.2714 L Standard Deviation 78.43782	290.5190 L Standard Deviation 160.50093	281.7423 L Standard Deviation 101.64610	655.4794 L Standard Deviation 320.11459	416.8746 L Standard Deviation 183.79449	807.4773 L Standard Deviation 200.14983	594.3399 L Standard Deviation 149.97225	1573.1600 L Standard Deviation 901.24407	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Vz/F was calculated as (CL/F)/λz.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) Day 1	442.5900 L Standard Deviation 248.99792	329.6057 L Standard Deviation 135.47030	632.4288 L Standard Deviation 438.98268	460.7824 L Standard Deviation 218.14865	698.3679 L Standard Deviation 373.79793	715.0788 L Standard Deviation 414.96986	—	—	—	—
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD) Day 9	366.8037 L Standard Deviation 178.07012	266.5672 L Standard Deviation 68.21454	565.3577 L Standard Deviation 252.08686	352.4564 L Standard Deviation 114.45822	530.4696 L Standard Deviation 211.00235	503.3324 L Standard Deviation 298.76176	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Ae(0-24) was calculated as calculated as Cur*Vur, where Cur was the concentration of drug excreted in urine and Vur is the volume of urine excreted.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD)	0.002473 mg Standard Deviation 0.0008033	0.009898 mg Standard Deviation 0.0049671	0.069183 mg Standard Deviation 0.0289653	0.128195 mg Standard Deviation 0.0412071	0.227985 mg Standard Deviation 0.0762743	0.507260 mg Standard Deviation 0.1109721	0.963253 mg Standard Deviation 0.3108451	2.010763 mg Standard Deviation 0.3615714	1.925176 mg Standard Deviation 0.6269670	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Ae(0-24) is calculated as calculated as Cur*Vur, where Cu was the concentration of drug excreted in urine and Vur is the volume of urine excreted.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) Day 1	0.086153 mg Standard Deviation 0.0362135	0.149595 mg Standard Deviation 0.0378613	0.418761 mg Standard Deviation 0.1666534	1.095832 mg Standard Deviation 0.4029873	1.186754 mg Standard Deviation 0.3087747	1.569498 mg Standard Deviation 0.3542760	—	—	—	—
Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD) Day 9	0.089955 mg Standard Deviation 0.0423540	0.181305 mg Standard Deviation 0.0555997	0.385163 mg Standard Deviation 0.1034764	1.004047 mg Standard Deviation 0.2138181	1.370011 mg Standard Deviation 0.3414174	2.165337 mg Standard Deviation 0.3525765	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD)	0.002473 mg Standard Deviation 0.0008033	0.009999 mg Standard Deviation 0.0049464	0.069676 mg Standard Deviation 0.0288376	0.128604 mg Standard Deviation 0.0411008	0.229946 mg Standard Deviation 0.0763608	0.514036 mg Standard Deviation 0.1144776	0.977421 mg Standard Deviation 0.3148372	2.062580 mg Standard Deviation 0.3829068	1.988120 mg Standard Deviation 0.6152605	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Fe was calculated as (Aet/dose)*100.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)	2.4733 percentage of TAK-020 dose Standard Deviation 0.80334	1.9796 percentage of TAK-020 dose Standard Deviation 0.99341	2.7673 percentage of TAK-020 dose Standard Deviation 1.15861	2.9135 percentage of TAK-020 dose Standard Deviation 0.93653	2.5907 percentage of TAK-020 dose Standard Deviation 0.86675	2.8986 percentage of TAK-020 dose Standard Deviation 0.63413	2.7522 percentage of TAK-020 dose Standard Deviation 0.88813	2.8725 percentage of TAK-020 dose Standard Deviation 0.51653	1.8335 percentage of TAK-020 dose Standard Deviation 0.59711	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Fe was calculated as (Aet/dose)*100.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) Day 1	2.2974 percentage of TAK-020 dose Standard Deviation 0.96569	2.6016 percentage of TAK-020 dose Standard Deviation 0.65846	3.2212 percentage of TAK-020 dose Standard Deviation 1.28195	4.3833 percentage of TAK-020 dose Standard Deviation 1.61195	2.6372 percentage of TAK-020 dose Standard Deviation 0.68617	2.6158 percentage of TAK-020 dose Standard Deviation 0.59046	—	—	—	—
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD) Day 9	2.3988 percentage of TAK-020 dose Standard Deviation 1.12944	3.1531 percentage of TAK-020 dose Standard Deviation 0.96695	2.9628 percentage of TAK-020 dose Standard Deviation 0.79597	4.0162 percentage of TAK-020 dose Standard Deviation 0.85527	3.0445 percentage of TAK-020 dose Standard Deviation 0.75871	3.6089 percentage of TAK-020 dose Standard Deviation 0.58763	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

Fe was calculated as (Aet/dose)*100.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)	2.4733 percentage of TAK-020 dose Standard Deviation 0.80334	1.9999 percentage of TAK-020 dose Standard Deviation 0.98928	2.7870 percentage of TAK-020 dose Standard Deviation 1.15351	2.9228 percentage of TAK-020 dose Standard Deviation 0.93411	2.6130 percentage of TAK-020 dose Standard Deviation 0.86774	2.9373 percentage of TAK-020 dose Standard Deviation 0.65416	2.7926 percentage of TAK-020 dose Standard Deviation 0.89953	2.9465 percentage of TAK-020 dose Standard Deviation 0.54701	1.8934 percentage of TAK-020 dose Standard Deviation 0.58596	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

CLr was calculated as (Ae96/AUCt)*100.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 Participants TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 Participants TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 Participants TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Renal Clearance (CLr) for TAK-020 in Part 1 (SRD)	3.6856 L/h Standard Deviation 1.20477	2.6010 L/h Standard Deviation 0.62075	2.5250 L/h Standard Deviation 1.30987	2.0190 L/h Standard Deviation 0.47688	2.2159 L/h Standard Deviation 0.15331	1.8896 L/h Standard Deviation 0.60426	2.6108 L/h Standard Deviation 1.03807	2.0007 L/h Standard Deviation 0.28823	2.1898 L/h Standard Deviation 0.63728	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.

CLr was calculated as (Ae24/AUC24)*100.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) Day 1	2.3165 L/h Standard Deviation 0.35669	1.7168 L/h Standard Deviation 0.42806	2.8969 L/h Standard Deviation 1.50559	2.6497 L/h Standard Deviation 0.42235	2.1525 L/h Standard Deviation 0.83694	1.9597 L/h Standard Deviation 0.52835	—	—	—	—
Renal Clearance (CLr) for TAK-020 in Part 2 (MRD) Day 9	2.0802 L/h Standard Deviation 0.36760	1.7732 L/h Standard Deviation 0.41318	2.6754 L/h Standard Deviation 1.08869	2.5311 L/h Standard Deviation 0.65737	2.2053 L/h Standard Deviation 0.80067	2.2405 L/h Standard Deviation 0.82268	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2

Population: Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.

Outcome measures

Measure	Part 1 Cohort 1-9: Placebo n=6 Participants TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 Participants TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 Participants TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 Participants TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 Participants TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 Participants TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.
R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) Day 9	3.665 ratio Standard Error 0.1578	4.608 ratio Standard Error 0.1578	4.992 ratio Standard Error 0.1578	5.993 ratio Standard Error 0.1728	6.475 ratio Standard Error 0.1578	6.919 ratio Standard Error 0.1578	—	—	—	—
R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD) Day 1	3.551 ratio Standard Error 0.1578	4.463 ratio Standard Error 0.1578	5.010 ratio Standard Error 0.1578	5.940 ratio Standard Error 0.1728	6.376 ratio Standard Error 0.1578	6.716 ratio Standard Error 0.1578	—	—	—	—

Adverse Events

Part 1 Cohort 1-9: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1 Cohort 1: TAK-020 0.1 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 Cohort 2: TAK-020 0.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 Cohort 3: TAK-020 2.5 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 Cohort 4: TAK-020 4.4 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 Cohort 5: TAK-020 8.8 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 Cohort 6: TAK-020 17.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 Cohort 7: TAK-020 35 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 Cohort 8: TAK-020 70 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1 Cohort 9: TAK-020 105 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2 Cohort 1-6: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2 Cohort 1: TAK-020 3.75 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2 Cohort 2: TAK-020 5.75 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2 Cohort 3: TAK-020 13 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2 Cohort 4: TAK-020 25 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 Cohort 5: TAK-020 45 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2 Cohort 6: TAK-020 60 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1 Cohort 1-9: Placebo n=18 participants at risk TAK-020 placebo-matching solution, orally, once on Day 1.	Part 1 Cohort 1: TAK-020 0.1 mg n=6 participants at risk TAK-020 0.1 milligram (mg), solution, orally once on Day 1.	Part 1 Cohort 2: TAK-020 0.5 mg n=6 participants at risk TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1.	Part 1 Cohort 3: TAK-020 2.5 mg n=6 participants at risk TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2.	Part 1 Cohort 4: TAK-020 4.4 mg n=6 participants at risk TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3.	Part 1 Cohort 5: TAK-020 8.8 mg n=6 participants at risk TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4.	Part 1 Cohort 6: TAK-020 17.5 mg n=6 participants at risk TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5.	Part 1 Cohort 7: TAK-020 35 mg n=6 participants at risk TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 6.	Part 1 Cohort 8: TAK-020 70 mg n=6 participants at risk TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 7.	Part 1 Cohort 9: TAK-020 105 mg n=6 participants at risk TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose was determined based on review of safety, tolerability and PK data from Cohort 8.	Part 2 Cohort 1-6: Placebo n=12 participants at risk TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9.	Part 2 Cohort 1: TAK-020 3.75 mg n=6 participants at risk TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study.	Part 2 Cohort 2: TAK-020 5.75 mg n=6 participants at risk TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2.	Part 2 Cohort 3: TAK-020 13 mg n=6 participants at risk TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2.	Part 2 Cohort 4: TAK-020 25 mg n=6 participants at risk TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2.	Part 2 Cohort 5: TAK-020 45 mg n=6 participants at risk TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2.	Part 2 Cohort 6: TAK-020 60 mg n=6 participants at risk TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2.
Gastrointestinal disorders Abdominal distension	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 upper	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.	8.3% 1/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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	5.6% 1/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 3/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.	33.3% 2/6 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Dizziness	5.6% 1/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 2/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Oropharyngeal pain	5.6% 1/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.	33.3% 2/6 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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	5.6% 1/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.
Vascular disorders Phlebitis	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.
Vascular disorders Phlebitis superficial	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Diarrhoea	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Lip dry	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Axillary pain	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Upper respiratory tract infection	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 2/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Musculoskeletal discomfort	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Hypoaesthesia	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Somnolence	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 2/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Nasal congestion	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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.	8.3% 1/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Rhinorrhoea	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Sinus congestion	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 Throat irritation	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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	0.00% 0/18 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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% 0/12 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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 • First dose of study drug up to and including 30 days after last dose of study drug ( 31 Days for Part 1 and 39 days for 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

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