Trial Outcomes & Findings for A Study of TAK-951 in Healthy Adults (NCT NCT04486950)
NCT ID: NCT04486950
Last Updated: 2023-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to Day 29
Results posted on
2023-03-10
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 07 July 2020 to 27 May 2021.
Healthy participants were randomized and treated sequentially in Cohorts: 1, 2, 3 and 4 to receive intravenous infusion of TAK-951 20 microgram (mcg), TAK-951 1.0 milligram (mg) or TAK-951 matching placebo (normal saline).
Participant milestones
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
TAK-951 placebo-matching (0.2 milliliter \[ml\] normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
2
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
2
|
2
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
TAK-951 placebo-matching (0.2 milliliter \[ml\] normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of TAK-951 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
29 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
29 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 29Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 29Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=6 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
|
2.758 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25.1
|
110.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 11.0
|
127.7 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23.9
|
133.2 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 9.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: at the end of infusion (at 30 hours post-infusion)Population: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=6 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=5 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Ceoi: Plasma Concentration at the End of Infusion for TAK-951
|
0.5203 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 143.2
|
48.95 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.9
|
37.03 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.4
|
27.06 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 9.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dosePopulation: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=6 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951
|
2.722 ng*hr/mL
Geometric Coefficient of Variation 25.4
|
110.0 ng*hr/mL
Geometric Coefficient of Variation 10.8
|
127.2 ng*hr/mL
Geometric Coefficient of Variation 24.0
|
132.5 ng*hr/mL
Geometric Coefficient of Variation 9.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dosePopulation: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=6 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
T1/2z: Terminal Disposition Phase Half-life for TAK-951
|
4.025 hour
Standard Deviation 0.7100
|
4.670 hour
Standard Deviation 0.5576
|
4.454 hour
Standard Deviation 0.5124
|
4.640 hour
Standard Deviation 0.3410
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dosePopulation: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=6 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=6 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
λz: Terminal Disposition Phase Rate Constant for TAK-951
|
0.1781 per hour (1/hour)
Standard Deviation 0.040265
|
0.1501 per hour (1/hour)
Standard Deviation 0.016879
|
0.1574 per hour (1/hour)
Standard Deviation 0.018543
|
0.1500 per hour (1/hour)
Standard Deviation 0.010488
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: The immunogenicity analysis set included those participants from the safety analysis set who had a baseline and at least 1 post-dose immunogenicity sample assessment.
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Outcome measures
| Measure |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 Participants
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 Participants
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 Participants
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 Participants
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohorts 1 to 2, Treatment P1: Placebo Pooled
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3, Treatment P2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4, Treatment P3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1, Treatment A: TAK-951 20 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2, Treatment B: TAK-951 1.0 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3, Treatment C: TAK-951 1.0 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4, Treatment D: TAK-951 1.0 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 |
Cohorts 1 to 2, Treatment P1: Placebo Pooled
n=4 participants at risk
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment P2: Placebo
n=2 participants at risk
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment P3: Placebo
n=2 participants at risk
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 1, Treatment A: TAK-951 20 mcg
n=6 participants at risk
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 2, Treatment B: TAK-951 1.0 mg
n=6 participants at risk
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 3, Treatment C: TAK-951 1.0 mg
n=6 participants at risk
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
|
Cohort 4, Treatment D: TAK-951 1.0 mg
n=6 participants at risk
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Back pain
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Joint swelling
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Medical device site reaction
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle spasms
|
25.0%
1/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Paraesthesia
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Respiratory tract congestion
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Vessel puncture site bruise
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
Vessel puncture site pain
|
0.00%
0/4 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29
At each visit the investigator had to document any occurrence of adverse events and 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
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