Trial Outcomes & Findings for A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants (NCT NCT04202497)

Results Overview

Enzyme binding parameter \[Ki\] was obtained from irreversible 2-tissue compartment model (mL/cm\^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm\^3/min signifies 'milliliter per cubic centimeter per minute'.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Day -1

Results posted on

2021-07-30

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 18 December 2019 to 19 March 2020.

Healthy participants were enrolled in this study to receive up to 10 millicurie \[mCi\]) of \[18F\]MNI-1054 for 1 positron emission tomography (PET) Scan on Day -1 (Baseline Scan), and then eligible participants entered into 1 of 3 treatment groups in the Treatment Period to receive 10 mCi of \[18F\]MNI-1054 for 2 PET scans after single dose of TAK-418 1.5 milligram (mg), 10 mg, or 30 mg on Day 1 and either Day 2 or 3. Study was prematurely terminated because of administrative reasons.

Participant milestones

Participant milestones
Measure	Baseline [18F]MNI-1054 \[18F\]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 1.5 mg TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Baseline Scan (Day-1) STARTED	7	0	0	0
Baseline Scan (Day-1) COMPLETED	6	0	0	0
Baseline Scan (Day-1) NOT COMPLETED	1	0	0	0
Treatment Period (Day 1 Through Day 2-3) STARTED	0	2	2	2
Treatment Period (Day 1 Through Day 2-3) COMPLETED	0	2	2	2
Treatment Period (Day 1 Through Day 2-3) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Baseline [18F]MNI-1054 \[18F\]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 1.5 mg TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Baseline Scan (Day-1) Metabolites of [18F]MNI-1054 could not be analyzed	1	0	0	0

Baseline Characteristics

A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline [18F]MNI-1054 n=7 Participants \[18F\]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Age, Continuous	43.7 years STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants
Body Mass Index (BMI)	26.81 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.594 • n=5 Participants

PRIMARY outcome

Timeframe: Day -1

Population: The pharmacodynamics (PD) set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418.

Enzyme binding parameter \[Ki\] was obtained from irreversible 2-tissue compartment model (mL/cm\^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm\^3/min signifies 'milliliter per cubic centimeter per minute'.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Cerebellum	0.03405 mL/cm^3/min Standard Deviation 0.002192	0.03515 mL/cm^3/min Standard Deviation 0.005869	0.03560 mL/cm^3/min Standard Deviation 0.003394	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Frontal Lobe	0.01930 mL/cm^3/min Standard Deviation 0.004525	0.02070 mL/cm^3/min Standard Deviation 0.004384	0.02140 mL/cm^3/min Standard Deviation 0.002263	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Hippocampus	0.01900 mL/cm^3/min Standard Deviation 0.000141	0.01935 mL/cm^3/min Standard Deviation 0.005303	0.01960 mL/cm^3/min Standard Deviation 0.001414	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Striatum	0.01575 mL/cm^3/min Standard Deviation 0.004031	0.01930 mL/cm^3/min Standard Deviation 0.004950	0.01995 mL/cm^3/min Standard Deviation 0.003323	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Occipital Lobe	0.02140 mL/cm^3/min Standard Deviation 0.002404	0.02225 mL/cm^3/min Standard Deviation 0.003606	0.02365 mL/cm^3/min Standard Deviation 0.002616	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1 Pons	0.01685 mL/cm^3/min Standard Deviation 0.000071	0.01855 mL/cm^3/min Standard Deviation 0.004313	0.01870 mL/cm^3/min Standard Deviation 0.004667	—

PRIMARY outcome

Timeframe: Day 1

Population: The PD set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418.

Enzyme binding parameter \[Ki\] was obtained from irreversible 2-tissue compartment model (mL/cm\^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm\^3/min signifies 'milliliter per cubic centimeter per minute'.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Cerebellum	0.01020 mL/cm^3/min Standard Deviation 0.003536	0.00405 mL/cm^3/min Standard Deviation 0.000495	0.00760 mL/cm^3/min Standard Deviation 0.000849	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Frontal Lobe	0.01295 mL/cm^3/min Standard Deviation 0.001768	0.00980 mL/cm^3/min Standard Deviation 0.001697	0.01435 mL/cm^3/min Standard Deviation 0.002333	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Hippocampus	0.01260 mL/cm^3/min Standard Deviation 0.000990	0.00635 mL/cm^3/min Standard Deviation 0.004031	0.01240 mL/cm^3/min Standard Deviation 0.000000	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Occipital Lobe	0.01245 mL/cm^3/min Standard Deviation 0.002758	0.00910 mL/cm^3/min Standard Deviation 0.000990	0.01430 mL/cm^3/min Standard Deviation 0.001556	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Pons	0.01265 mL/cm^3/min Standard Deviation 0.006718	0.00970 mL/cm^3/min Standard Deviation 0.000707	0.01515 mL/cm^3/min Standard Deviation 0.000212	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1 Striatum	0.01185 mL/cm^3/min Standard Deviation 0.002192	0.00785 mL/cm^3/min Standard Deviation 0.000495	0.01365 mL/cm^3/min Standard Deviation 0.000071	—

PRIMARY outcome

Timeframe: Day 2

Population: The PD set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418.

Enzyme binding parameter \[Ki\] was obtained from irreversible 2-tissue compartment model (mL/cm\^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm\^3/min signifies 'milliliter per cubic centimeter per minute'.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Cerebellum	0.01865 mL/cm^3/min Standard Deviation 0.004455	0.00875 mL/cm^3/min Standard Deviation 0.001485	0.00690 mL/cm^3/min Standard Deviation 0.000566	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Hippocampus	0.01650 mL/cm^3/min Standard Deviation 0.003960	0.00865 mL/cm^3/min Standard Deviation 0.001061	0.01015 mL/cm^3/min Standard Deviation 0.000919	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Occipital Lobe	0.01665 mL/cm^3/min Standard Deviation 0.003889	0.01045 mL/cm^3/min Standard Deviation 0.002192	0.01180 mL/cm^3/min Standard Deviation 0.001980	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Pons	0.01265 mL/cm^3/min Standard Deviation 0.004738	0.01045 mL/cm^3/min Standard Deviation 0.002475	0.00985 mL/cm^3/min Standard Deviation 0.000636	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Striatum	0.01410 mL/cm^3/min Standard Deviation 0.004667	0.00915 mL/cm^3/min Standard Deviation 0.003182	0.00965 mL/cm^3/min Standard Deviation 0.001344	—
Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2 Frontal Lobe	0.01610 mL/cm^3/min Standard Deviation 0.003111	0.01020 mL/cm^3/min Standard Deviation 0.001838	0.01130 mL/cm^3/min Standard Deviation 0.002404	—

PRIMARY outcome

Timeframe: Day 1

Population: The PD set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418.

Lysine-Specific Demethylase 1A (LSD1) enzyme occupancy (%) in region of interest (ROI) after a single dose of TAK-418 was obtained from the baseline and postdose Ki values as follows: occupancy (1st postdose) = 100\*(Ki \[baseline\] - Ki \[1st postdose\]) / Ki (baseline). Data is reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Cerebellum	68.5 percentage of occupancy Standard Deviation 10.61	87.0 percentage of occupancy Standard Deviation 1.41	79.5 percentage of occupancy Standard Deviation 2.12	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Hippocampus	33.0 percentage of occupancy Standard Deviation 5.66	59.5 percentage of occupancy Standard Deviation 26.16	40.0 percentage of occupancy Standard Deviation 0.00	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Occipital Lobe	37.0 percentage of occupancy Standard Deviation 14.14	54.5 percentage of occupancy Standard Deviation 4.95	43.5 percentage of occupancy Standard Deviation 6.36	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Pons	25.0 percentage of occupancy Standard Deviation 39.60	37.5 percentage of occupancy Standard Deviation 4.95	31.0 percentage of occupancy Standard Deviation 1.41	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Striatum	8.0 percentage of occupancy Standard Deviation 16.97	50.5 percentage of occupancy Standard Deviation 3.54	39.0 percentage of occupancy Standard Deviation 0.00	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1 Frontal Lobe	19.5 percentage of occupancy Standard Deviation 10.61	44.0 percentage of occupancy Standard Deviation 9.90	38.0 percentage of occupancy Standard Deviation 9.90	—

PRIMARY outcome

Timeframe: Day 2

Population: The PD set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418.

LSD1 enzyme occupancy (%) in ROI after a single dose of TAK-418 was obtained from the baseline and postdose Ki values as follows: occupancy (2nd postdose) = 100\*(Ki \[baseline\] - Ki \[2nd postdose\]) / Ki (baseline). Data is reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Cerebellum	42.5 percentage of occupancy Standard Deviation 13.44	71.5 percentage of occupancy Standard Deviation 4.95	82.0 percentage of occupancy Standard Deviation 1.41	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Frontal Lobe	0.5 percentage of occupancy Standard Deviation 19.09	42.0 percentage of occupancy Standard Deviation 9.90	51.0 percentage of occupancy Standard Deviation 9.90	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Hippocampus	13.0 percentage of occupancy Standard Deviation 21.21	44.5 percentage of occupancy Standard Deviation 6.36	50.5 percentage of occupancy Standard Deviation 4.95	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Occipital Lobe	16.0 percentage of occupancy Standard Deviation 19.80	47.0 percentage of occupancy Standard Deviation 11.31	53.5 percentage of occupancy Standard Deviation 7.78	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Pons	25.0 percentage of occupancy Standard Deviation 28.28	32.5 percentage of occupancy Standard Deviation 16.26	55.0 percentage of occupancy Standard Deviation 2.83	—
Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2 Striatum	-9.0 percentage of occupancy Standard Deviation 35.36	42.0 percentage of occupancy Standard Deviation 19.80	56.5 percentage of occupancy Standard Deviation 6.36	—

PRIMARY outcome

Timeframe: Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan

Population: The pharmacokinetic (PK) set included all participants from the safety set who received TAK-418 and had at least 1 measurable plasma concentration for TAK-418.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Cmax: Maximum Observed Plasma Concentration for TAK-418	4.420 nanogram per milliliter (ng/mL) Interval 4.23 to 4.61	43.80 nanogram per milliliter (ng/mL) Interval 36.7 to 50.9	130.5 nanogram per milliliter (ng/mL) Interval 127.0 to 134.0	—

PRIMARY outcome

Timeframe: Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan

Population: The PK set included all participants from the safety set who received TAK-418 and had at least 1 measurable plasma concentration for TAK-418.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=2 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-418	22.40 hournanogram per milliliter(hng/mL) Interval 20.8 to 24.0	227.5 hournanogram per milliliter(hng/mL) Interval 223.0 to 232.0	812.0 hournanogram per milliliter(hng/mL) Interval 718.0 to 906.0	—

PRIMARY outcome

Timeframe: Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan

Population: The PK set included all participants from the safety set who received TAK-418 and had at least 1 measurable plasma concentration for TAK-418. Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=1 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418	25.60 h*ng/mL Interval 25.6 to 25.6	230.0 h*ng/mL Interval 225.0 to 235.0	817.0 h*ng/mL Interval 721.0 to 913.0	—

SECONDARY outcome

Timeframe: Days 1 to 2

Population: The PD set included all participants who received TAK-418 and have at least 1 analyzable PET Scan following TAK-418

The relationship between PET enzyme occupancy and TAK-418 dose level was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and dose that gives 50 percent (%) of Emax (ED50). ED50 values are reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. The data tabulated are the estimated value and confidence intervals of the ED50 value derived from an Emax model fit across all data points from all arms. ED50 is the dose at which 50% enzyme occupancy is expected.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=6 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
ED50 PET Enzyme Occupancy Cerebellum	0.756 milligram (mg) Interval 0.288 to 1.224	—	—	—
ED50 PET Enzyme Occupancy Frontal Lobe	4.328 milligram (mg) Interval 0.129 to 8.527	—	—	—
ED50 PET Enzyme Occupancy Hippocampus	1.639 milligram (mg) Interval -0.098 to 3.377	—	—	—
ED50 PET Enzyme Occupancy Occipital Lobe	1.416 milligram (mg) Interval 0.141 to 2.69	—	—	—
ED50 PET Enzyme Occupancy Pons	1.112 milligram (mg) Interval -0.976 to 3.2	—	—	—
ED50 PET Enzyme Occupancy Striatum	7.496 milligram (mg) Interval -2.05 to 17.04	—	—	—

SECONDARY outcome

Timeframe: From first dose of [18F]MNI-1054 radiotracer injection up to Day 14

Population: The safety set included all enrolled participants who received at least 1 dose of \[18F\]MNI-1054 or TAK-418

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=7 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Number of Participants Reporting One or More Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants Reporting One or More Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of [18F]MNI-1054 radiotracer injection up to Day 14

Population: The safety set included all enrolled participants who received at least 1 dose of \[18F\]MNI-1054 or TAK-418

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=7 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Number of Participants With Clinically Significant Abnormal Laboratory Values	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of [18F]MNI-1054 radiotracer injection up to Day 14

Population: The safety set included all enrolled participants who received at least 1 dose of \[18F\]MNI-1054 or TAK-418.

Outcome measures

Outcome measures
Measure	TAK-418 1.5 mg n=7 Participants TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 Participants TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 Participants TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Number of Participants With Clinically Significant Abnormal Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Baseline [18F]MNI-1054

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TAK-418 1.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAK-418 10 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TAK-418 30 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Baseline [18F]MNI-1054 n=7 participants at risk \[18F\]MNI-1054 up to 10 mCi, PET radiotracer injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 1.5 mg n=2 participants at risk TAK-418 1.5 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 10 mg n=2 participants at risk TAK-418 10 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).	TAK-418 30 mg n=2 participants at risk TAK-418 30 mg, capsule, orally, once on Day 1 and up to 10 mCi of \[18F\]MNI-1054 PET radiotracer injection, intravenously, prior to each PET scans on Day 1, and either on Day 2 or 3 post-TAK-418 dose in the Treatment Period. All participants received \[18F\]MNI-1054 up to 10 mCi, injection, intravenously, prior to PET scan on Day -1 (Baseline scan).
Nervous system disorders Somnolence	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and 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 Arthralgia	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/7 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 2/2 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	14.3% 1/7 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first administration of [18F]MNI-1054 radiotracer injection until the Day 14 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

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