Trial Outcomes & Findings for Phase 1, TAK-648, Single-Rising Dose Study (NCT NCT02684396)
NCT ID: NCT02684396
Last Updated: 2016-07-13
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2016-07-13
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 19 August 2014 to 08 July 2015.
Healthy Volunteers were enrolled in 1 of 6 treatment groups, once a day placebo, TAK-648 0.05 mg, 0.15 mg, 0.35 mg, 0.7 mg or 0.85 mg.
Participant milestones
| Measure |
Cohort 1: TAK-648 0.05 mg
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
5
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1, TAK-648, Single-Rising Dose Study
Baseline characteristics by cohort
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 Participants
TAK-648 placebo-matching solution, orally, once on Day 1.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 9.78 • n=4 Participants
|
45.0 years
STANDARD_DEVIATION 11.51 • n=21 Participants
|
36.2 years
STANDARD_DEVIATION 11.10 • n=10 Participants
|
37.5 years
STANDARD_DEVIATION 10.86 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
10 participants
n=10 Participants
|
27 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
9 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=10 Participants
|
25 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
10 participants
n=10 Participants
|
39 participants
n=115 Participants
|
|
Height
|
177.2 cm
STANDARD_DEVIATION 9.24 • n=5 Participants
|
169.0 cm
STANDARD_DEVIATION 8.58 • n=7 Participants
|
172.2 cm
STANDARD_DEVIATION 11.82 • n=5 Participants
|
163.3 cm
STANDARD_DEVIATION 8.21 • n=4 Participants
|
170.6 cm
STANDARD_DEVIATION 12.26 • n=21 Participants
|
176.4 cm
STANDARD_DEVIATION 8.46 • n=10 Participants
|
172.0 cm
STANDARD_DEVIATION 10.19 • n=115 Participants
|
|
Weight
|
76.1 kg
STANDARD_DEVIATION 12.39 • n=5 Participants
|
70.0 kg
STANDARD_DEVIATION 9.32 • n=7 Participants
|
75.6 kg
STANDARD_DEVIATION 12.86 • n=5 Participants
|
67.1 kg
STANDARD_DEVIATION 4.36 • n=4 Participants
|
76.1 kg
STANDARD_DEVIATION 12.79 • n=21 Participants
|
77.7 kg
STANDARD_DEVIATION 14.33 • n=10 Participants
|
74.1 kg
STANDARD_DEVIATION 11.71 • n=115 Participants
|
|
Body Mass Index (BMI)
|
24.3 kg/m^2
STANDARD_DEVIATION 3.60 • n=5 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 2.42 • n=7 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 2.37 • n=5 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 2.73 • n=4 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 2.26 • n=21 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 3.03 • n=10 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 2.69 • n=115 Participants
|
|
Hip Circumference
|
99.33 cm
STANDARD_DEVIATION 6.683 • n=5 Participants
|
96.33 cm
STANDARD_DEVIATION 3.141 • n=7 Participants
|
98.50 cm
STANDARD_DEVIATION 8.385 • n=5 Participants
|
102.83 cm
STANDARD_DEVIATION 4.956 • n=4 Participants
|
102.20 cm
STANDARD_DEVIATION 4.207 • n=21 Participants
|
98.63 cm
STANDARD_DEVIATION 7.121 • n=10 Participants
|
99.47 cm
STANDARD_DEVIATION 6.180 • n=115 Participants
|
|
Waist Circumference
|
86.83 cm
STANDARD_DEVIATION 9.174 • n=5 Participants
|
82.50 cm
STANDARD_DEVIATION 6.863 • n=7 Participants
|
90.00 cm
STANDARD_DEVIATION 5.762 • n=5 Participants
|
86.17 cm
STANDARD_DEVIATION 7.548 • n=4 Participants
|
95.00 cm
STANDARD_DEVIATION 3.391 • n=21 Participants
|
88.06 cm
STANDARD_DEVIATION 10.865 • n=10 Participants
|
87.91 cm
STANDARD_DEVIATION 8.420 • n=115 Participants
|
|
Waist to Hip Ratio
|
0.87 ratio
STANDARD_DEVIATION 0.037 • n=5 Participants
|
0.86 ratio
STANDARD_DEVIATION 0.061 • n=7 Participants
|
0.92 ratio
STANDARD_DEVIATION 0.038 • n=5 Participants
|
0.84 ratio
STANDARD_DEVIATION 0.074 • n=4 Participants
|
0.93 ratio
STANDARD_DEVIATION 0.034 • n=21 Participants
|
0.89 ratio
STANDARD_DEVIATION 0.069 • n=10 Participants
|
0.88 ratio
STANDARD_DEVIATION 0.061 • n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 Participants
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)
|
0 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
30.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 4Population: Safety Analysis Set included all enrolled participants who received study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 Participants
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Chemistry
|
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 Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Hematology
|
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 Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
Urinalysis
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 4Population: Safety Analysis Set included all enrolled participants who received study drug.
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 Participants
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
< Lower Criteria
|
33.3 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
> Upper Criteria
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
20.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 4Population: Safety Analysis Set included all enrolled participants who received study drug.
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 Participants
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose
|
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: Multiple time-points (up to 72 hours) post-dosePopulation: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-648
|
0.619 ng/mL
Standard Deviation 0.2461
|
2.330 ng/mL
Standard Deviation 0.8022
|
3.997 ng/mL
Standard Deviation 1.5958
|
11.845 ng/mL
Standard Deviation 2.6415
|
11.712 ng/mL
Standard Deviation 6.2166
|
—
|
SECONDARY outcome
Timeframe: Multiple time-points (up to 72 hours) post-dosePopulation: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648
|
1.000 hours
Interval 0.5 to 2.0
|
1.500 hours
Interval 1.0 to 1.5
|
1.000 hours
Interval 0.5 to 1.5
|
1.000 hours
Interval 0.5 to 1.5
|
1.000 hours
Interval 1.0 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Multiple time-points (up to 72 hours) post-dosePopulation: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
|
4.452 ng*hr/mL
Standard Deviation 2.2891
|
16.614 ng*hr/mL
Standard Deviation 4.6927
|
27.927 ng*hr/mL
Standard Deviation 9.5790
|
75.280 ng*hr/mL
Standard Deviation 25.2406
|
92.661 ng*hr/mL
Standard Deviation 30.0958
|
—
|
SECONDARY outcome
Timeframe: Multiple time-points (up to 72 hours) post-dosePopulation: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
Outcome measures
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 Participants
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 Participants
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 Participants
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 Participants
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 Participants
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
|
4.585 ng*hr/mL
Standard Deviation 2.2743
|
16.813 ng*hr/mL
Standard Deviation 4.6918
|
28.266 ng*hr/mL
Standard Deviation 9.5872
|
75.774 ng*hr/mL
Standard Deviation 25.3966
|
93.840 ng*hr/mL
Standard Deviation 30.8531
|
—
|
Adverse Events
Cohort 1: TAK-648 0.05 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: TAK-648 0.15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: TAK-648 0.35 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: TAK-648 0.7 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: TAK-648 0.85 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1-5: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: TAK-648 0.05 mg
n=6 participants at risk
TAK-648 0.05 mg, solution, orally, once on Day 1.
|
Cohort 2: TAK-648 0.15 mg
n=6 participants at risk
TAK-648 0.15 mg, solution, orally, once on Day 1.
|
Cohort 3: TAK-648 0.35 mg
n=6 participants at risk
TAK-648 0.35 mg, solution, orally, once on Day 1.
|
Cohort 4: TAK-648 0.7 mg
n=6 participants at risk
TAK-648 0.7 mg, solution, orally, once on Day 1.
|
Cohort 5: TAK-648 0.85 mg
n=5 participants at risk
TAK-648 0.85 mg, solution, orally, once on Day 1.
|
Cohort 1-5: Placebo
n=10 participants at risk
TAK-648 placebo-matching solution, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
16.7%
1/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
16.7%
1/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
16.7%
1/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure orthostatic abnormal
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
16.7%
1/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
20.0%
1/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
20.0%
2/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
10.0%
1/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
33.3%
2/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/6 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/5 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
0.00%
0/10 • 14 Days
At each visit the investigator had to document any occurrence of adverse events irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER