Healthy Participants, Parkinson Disease
Conditions
Keywords
Drug Therapy
Brief summary
It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071. Another aim is to see if it improves how participants think and remember. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 groups by chance. Both groups will have 2 treatments but in a different order. The treatments are TAK-071 tablets or placebo. In this study, a placebo will look like the TAK-071 but will not have any medicine in it. One group will take TAK-071 for 6 weeks, have at least a 3-week break, then take a placebo for 6 weeks. The other group will take a placebo for 6 weeks, have at least a 3-week break, then take TAK-071 for 6 weeks. The participants will not know the order of their 2 treatments, nor will their study doctors. This is to help make sure the results are more reliable. The participants will visit the clinic at the beginning and end of each treatment for a check-up. 14 days after the 2nd treatment, clinic staff will telephone the participants for a final check-up.
Detailed description
The drug being tested in this study is TAK-071. TAK-071 is being tested to treat people with PD who have cognitive impairment and are at risk for falls and who are not concurrently taking acetylcholinesterase inhibitors. The study will look at the efficacy and safety of TAK-071 in participants with PD who take TAK-071 versus placebo. The study will also evaluate the PK of TAK-071 in healthy participants (sentinel cohort) older than 55 years. The study will enroll approximately 74 participants. An initial sentinel cohort of 10 healthy participants will be included to estimate age effects. Participants aged 56 to 75 years will be randomly assigned in 3:1 ratio to one of the two treatments: * Sentinel Cohort: TAK-071 7.5 mg * Sentinel Cohort: Placebo Enrolment for participants aged 40 to ≤ 85 years in the main study will start simultaneously with sentinel cohort. Based on PK, safety, and physiologically based PK modelling data from sentinel cohort, dosing will be decided for the remaining participants. Participants with maximum age of 66 to 85 years, inclusive, will be enrolled at a dose of 5 mg, and the dose for subjects aged 40 to 65 years, inclusive, will be 7.5 mg. All participants will be asked to take one tablet at the same time each day throughout the study. The remaining participants aged 40 years to \<=85 years will be randomly assigned in 1:1 ratio to one of two treatment sequences in crossover design: * TAK-071 + Placebo * Placebo + TAK-071 The study will be conducted in the United States. The minimum time to participate in this study is approximately 15 weeks. Participants will make multiple visits to the clinic and will have home assessments during the third Week of each 6-week treatment period, and will be contacted by telephone at 14 days after completion of the last period for a follow-up assessment.
Interventions
DRUGTAK-071
TAK-071 tablet.
DRUGPlacebo
TAK-071 placebo-matching tablet.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Is an outpatient of any sex aged between 40 and ≤ 85 years, inclusive, at the time of consent. 2. Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (i.e., dementia diagnosed before onset of motor symptoms or up to 1 year after onset of motor symptoms) are also eligible, consistent with MDS clinical diagnostic criteria for PD. 3. Has Hoehn and Yahr stage ≥2 and \<4 at the screening visit. 4. Has elevated risk for falls as indicated by at least 1 fall in the last 12 months before the screening visit based on the Fall History Assessment where in the opinion of the investigator the falls were a consequence of PD and are at continued elevated risk of falls per investigator judgment. Investigator judgment on fall risk may be informed by information such as, but not limited to, history, physical examination and/or a score ≥2 on item 3.10 on Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. 5. Has evidence of cognitive impairment as indicated by a Montreal Cognitive Assessment (MoCA) score between 11 and 26, inclusive and additionally can complete the cognitive assessments at screening (as specified in the study manual). 6. Can walk without aid for 2 minutes while doing serial 3 subtraction (with site staff ensuring participant safety in case of falls). Participants who require aids for walking can be included as long as they can complete the walk test without aid. Inclusion For Healthy Participants: 1\. The participant is a healthy individual of either sex aged between 56 and 75 years, inclusive (for initial set of participant in the sentinel cohort) at the time of consent. Older participants may be enrolled after analysis of data from participants aged 56 to 75 years, inclusive. NOTE: Other protocol defined Inclusion/
Exclusion criteria
may apply Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 and Week 6 (for each study period) | 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. |
| Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants | Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours) | — |
| Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants | Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours) | — |
| Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants | Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dose | — |
| Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants | Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours) | — |
| Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants | Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Cohort, Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-071 in PD Participants | Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort: Change From Baseline in Global Cognition Z-score | Baseline and Week 6 (for each study period) | 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. |
| Main Cohort: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in PD Participants | Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants | Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants | Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-071 in PD Participants | Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in PD Participants | Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
| Main Cohort, AUCtau: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-071 in PD Participants | Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 25 investigative sites in the United States from 21 October 2020 to 27 February 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 26 |
| 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). | 28 |
| Sentinel Cohort: Placebo (Healthy Participants) A single dose of TAK-071 placebo-matching, tablet, orally, on Day 1. | 2 |
| Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants) A single dose of TAK-071, 7.5 mg tablet, orally, on Day 1. | 8 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 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
| Characteristic | Total | Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants) | Placebo Then TAK-071 (PD Participants) | Sentinel Cohort: Placebo (Healthy Participants) | TAK-071 Then Placebo (PD Participants) |
|---|---|---|---|---|---|
| Age, Continuous | 67.4 years | 65.8 years | 69.0 years | 64.5 years | 70.4 years |
| Body Mass Index (BMI) | 26.80 kilograms per meters square (kg/m^2) | 26.706 kilograms per meters square (kg/m^2) | 26.354 kilograms per meters square (kg/m^2) | 26.338 kilograms per meters square (kg/m^2) | 27.813 kilograms per meters square (kg/m^2) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 6 Participants | 25 Participants | 2 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.5 centimeters (cm) | 172.63 centimeters (cm) | 177.42 centimeters (cm) | 165.75 centimeters (cm) | 174.49 centimeters (cm) |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 55 Participants | 7 Participants | 22 Participants | 1 Participants | 25 Participants |
| Sex: Female, Male Female | 16 Participants | 5 Participants | 3 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 48 Participants | 3 Participants | 23 Participants | 0 Participants | 22 Participants |
| Weight | 80.05 kilograms (kg) | 79.23 kilograms (kg) | 83.45 kilograms (kg) | 72.90 kilograms (kg) | 84.63 kilograms (kg) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 53 | 0 / 2 | 0 / 8 |
| other Total, other adverse events | 2 / 49 | 5 / 53 | 2 / 2 | 3 / 8 |
| serious Total, serious adverse events | 1 / 49 | 2 / 53 | 0 / 2 | 0 / 8 |
Outcome results
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Without Cognitive Load: Placebo | 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 |
| Without Cognitive Load: Placebo | 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 |
| Without Cognitive Load: TAK-071 | 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 | 0.0607 seconds | Standard Deviation 0.05666 |
| Without Cognitive Load: TAK-071 | 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 | 0.0625 seconds | Standard Deviation 0.05601 |
| With Cognitive Load: Placebo | 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 | 0.0930 seconds | Standard Deviation 0.07743 |
| With Cognitive Load: Placebo | 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 | 0.0848 seconds | Standard Deviation 0.07894 |
| With Cognitive Load: TAK-071 | 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 | 0.0861 seconds | Standard Deviation 0.06047 |
| With Cognitive Load: TAK-071 | 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 | 0.0925 seconds | Standard Deviation 0.08156 |
Primary
Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants
Time frame: Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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 |
Primary
Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants | 186 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
Primary
Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without Cognitive Load: Placebo | Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants | 1.50 hours |
Secondary
Main Cohort: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in PD Participants
Time frame: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Main Cohort, AUCtau: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-071 in PD Participants
Time frame: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Main Cohort: Change From Baseline in Global Cognition Z-score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | Main Cohort: Change From Baseline in Global Cognition Z-score | -0.059 Z-score | Standard Deviation 0.3671 |
| Without Cognitive Load: TAK-071 | Main Cohort: Change From Baseline in Global Cognition Z-score | 0.208 Z-score | Standard Deviation 0.394 |
Secondary
Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants
Time frame: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants | 125 ng/mL | Geometric Coefficient of Variation 33.4 |
Secondary
Main Cohort: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-071 in PD Participants
Time frame: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants
Time frame: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Without Cognitive Load: Placebo | 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
Main Cohort, Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-071 in PD Participants
Time frame: Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without Cognitive Load: Placebo | Main Cohort, Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-071 in PD Participants | 2.10 hours |
Secondary
Main Cohort: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in PD Participants
Time frame: Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without Cognitive Load: Placebo | Main Cohort: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in PD Participants | 1.75 hours |