Trial Outcomes & Findings for A Study of TAK-071 in People With Parkinson Disease (NCT NCT04334317)
NCT ID: NCT04334317
Last Updated: 2024-05-14
Results Overview
Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline and Week 6 (for each study period)
Results posted on
2024-05-14
Participant Flow
Participants took part in the study at 25 investigative sites in the United States from 21 October 2020 to 27 February 2023.
Healthy participants were enrolled in the sentinel cohort of the study to receive TAK-071 and Placebo. Along with the sentinel cohort, participants diagnosed with Parkinson disease were enrolled in one of two sequences to receive treatment with either placebo then TAK-071 in sequence 1, or TAK-071 then placebo in sequence 2.
Participant milestones
| Measure |
Placebo Then TAK-071 (PD Participants)
TAK-071 placebo-matching tablets, orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by 5 or 7.5 milligrams (mg) TAK-071 tablets - depending on the participant's age orally, once daily for the next 6 weeks (Period 2).
|
TAK-071 Then Placebo (PD Participants)
Either 5 or 7.5 mg TAK-071 tablets - depending on the participant's age orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for the next 6 weeks (Period 2).
|
Sentinel Cohort: Placebo (Healthy Participants)
A single dose of TAK-071 placebo-matching tablet, orally, on Day 1.
|
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
A single dose of TAK-071, 7.5 mg tablet, orally, on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
2
|
8
|
|
Overall Study
COMPLETED
|
23
|
23
|
2
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then TAK-071 (PD Participants)
TAK-071 placebo-matching tablets, orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by 5 or 7.5 milligrams (mg) TAK-071 tablets - depending on the participant's age orally, once daily for the next 6 weeks (Period 2).
|
TAK-071 Then Placebo (PD Participants)
Either 5 or 7.5 mg TAK-071 tablets - depending on the participant's age orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for the next 6 weeks (Period 2).
|
Sentinel Cohort: Placebo (Healthy Participants)
A single dose of TAK-071 placebo-matching tablet, orally, on Day 1.
|
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
A single dose of TAK-071, 7.5 mg tablet, orally, on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
Baseline Characteristics
A Study of TAK-071 in People With Parkinson Disease
Baseline characteristics by cohort
| Measure |
Placebo Then TAK-071 (PD Participants)
n=26 Participants
TAK-071 placebo-matching tablets, orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by 5 or 7.5 milligrams (mg) TAK-071 tablets - depending on the participant's age-orally, once daily for the next 6 weeks (Period 2).
|
TAK-071 Then Placebo (PD Participants)
n=28 Participants
Either 5 or 7.5 mg TAK-071 tablets - depending on the participant's age orally, once daily for the first 6 weeks (Period 1), followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for the next 6 weeks (Period 2).
|
Sentinel Cohort: Placebo (Healthy Participants)
n=2 Participants
A single dose of TAK-071 placebo-matching, tablet, orally, on Day 1.
|
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
n=8 Participants
A single dose of TAK-071, 7.5 mg tablet, orally, on Day 1.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
n=5 Participants
|
70.4 years
n=7 Participants
|
64.5 years
n=5 Participants
|
65.8 years
n=4 Participants
|
67.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Weight
|
83.45 kilograms (kg)
n=5 Participants
|
84.63 kilograms (kg)
n=7 Participants
|
72.90 kilograms (kg)
n=5 Participants
|
79.23 kilograms (kg)
n=4 Participants
|
80.05 kilograms (kg)
n=21 Participants
|
|
Height
|
177.42 centimeters (cm)
n=5 Participants
|
174.49 centimeters (cm)
n=7 Participants
|
165.75 centimeters (cm)
n=5 Participants
|
172.63 centimeters (cm)
n=4 Participants
|
172.5 centimeters (cm)
n=21 Participants
|
|
Body Mass Index (BMI)
|
26.354 kilograms per meters square (kg/m^2)
n=5 Participants
|
27.813 kilograms per meters square (kg/m^2)
n=7 Participants
|
26.338 kilograms per meters square (kg/m^2)
n=5 Participants
|
26.706 kilograms per meters square (kg/m^2)
n=4 Participants
|
26.80 kilograms per meters square (kg/m^2)
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6 (for each study period)Population: Pharmacodynamic (PD) analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable pharmacodynamic endpoint. Overall number of participants analyzed are the number of participants with data available for analysis. Number analyzed are the number of participants with data available for analysis at given timepoint.
Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=47 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
n=47 Participants
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
n=47 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
n=45 Participants
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo
Baseline
|
0.0546 seconds
Standard Deviation 0.03919
|
0.0625 seconds
Standard Deviation 0.05601
|
0.0930 seconds
Standard Deviation 0.07743
|
0.0861 seconds
Standard Deviation 0.06047
|
|
Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo
Week 6
|
0.0534 seconds
Standard Deviation 0.03638
|
0.0607 seconds
Standard Deviation 0.05666
|
0.0848 seconds
Standard Deviation 0.07894
|
0.0925 seconds
Standard Deviation 0.08156
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)Population: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=8 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants
|
186 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)Population: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=8 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants
|
1.50 hours
Interval 1.0 to 8.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=8 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants
|
3050 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)Population: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=8 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants
|
11800 h*ng/mL
Geometric Coefficient of Variation 19.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)Population: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=8 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants
|
14600 h*ng/mL
Geometric Coefficient of Variation 28.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 6 (for each study period)Population: PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable pharmacodynamic endpoint. Overall number of participants analyzed are the number of participants with data available for analysis.
The global cognition score was calculated as the average of the available z-scores derived from the following individual cognitive tests administered in the cognitive test battery: 'Executive Function' assessed by One Back Test, Modified Groton Maze Learning Test, 'Memory' assessed by One Card Learning Test, International Shopping List Test - Immediate and Delayed Recall Tests, and 'Attention' assessed by Sustained Attention Test and Symbol Digit Modalities Test. Each raw score on the individual tests was converted to a z-score. A global z-score was calculated as an average of the individual z-scores. As the analysis is based on z-scores, there is no minimum or maximum value. An individual z-score of 0 means the observed score is the same as the group mean score at baseline. A positive z-score means the observed score is better (improvement in cognition) than the group mean score at baseline.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=45 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
n=38 Participants
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: Change From Baseline in Global Cognition Z-score
|
-0.059 Z-score
Standard Deviation 0.3671
|
0.208 Z-score
Standard Deviation 0.3940
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=44 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants
|
339 ng/mL
Geometric Coefficient of Variation 43.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=53 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants
|
125 ng/mL
Geometric Coefficient of Variation 33.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=44 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-071 in PD Participants
|
480 ng/mL
Geometric Coefficient of Variation 34.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=53 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in PD Participants
|
2360 h*ng/mL
Geometric Coefficient of Variation 32.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=44 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort, AUCtau: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-071 in PD Participants
|
9360 h*ng/mL
Geometric Coefficient of Variation 38.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=53 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort, Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-071 in PD Participants
|
2.10 hours
Interval 1.3 to 12.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dosePopulation: PK analysis set consisted of all participants who received at least 1 dose of TAK-071 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Without Cognitive Load: Placebo
n=44 Participants
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Without Cognitive Load: TAK-071
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
With Cognitive Load: Placebo
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
With Cognitive Load: TAK-071
TAK-071 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
|---|---|---|---|---|
|
Main Cohort: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in PD Participants
|
1.75 hours
Interval 1.1 to 6.0
|
—
|
—
|
—
|
Adverse Events
Main Cohort: Placebo (PD Participants)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Main Cohort: TAK-071 (PD Participants)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Sentinel Cohort: Placebo (Healthy Participants)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Cohort: Placebo (PD Participants)
n=49 participants at risk
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Main Cohort: TAK-071 (PD Participants)
n=53 participants at risk
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
Sentinel Cohort: Placebo (Healthy Participants)
n=2 participants at risk
A single dose of TAK-071 placebo-matching tablet, orally, on Day 1.
|
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
n=8 participants at risk
A single dose of TAK-071, 5 or 7.5 mg tablet, orally, on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.0%
1/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
3.8%
2/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
Other adverse events
| Measure |
Main Cohort: Placebo (PD Participants)
n=49 participants at risk
TAK-071 placebo-matching tablet, orally, once daily for main cohort.
|
Main Cohort: TAK-071 (PD Participants)
n=53 participants at risk
TAK-071, 5 or 7.5 mg tablet, orally, once daily for main cohort.
|
Sentinel Cohort: Placebo (Healthy Participants)
n=2 participants at risk
A single dose of TAK-071 placebo-matching tablet, orally, on Day 1.
|
Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)
n=8 participants at risk
A single dose of TAK-071, 5 or 7.5 mg tablet, orally, on Day 1.
|
|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
12.5%
1/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
7.5%
4/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
50.0%
1/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
25.0%
2/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
12.5%
1/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
1.9%
1/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
50.0%
1/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/49 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/53 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
0.00%
0/2 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
12.5%
1/8 • From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days)
Safety set consisted of all participants who were randomized and receive at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER