Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Inclusion Criteria

Healthy Participants and Participants with Schizophrenia:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any participant procedures including requesting that a participant fast for any laboratory evaluations.
• The participant is willing to comply with study restrictions described in the protocol.
• The participant is a healthy adult man or woman (of non-childbearing potential as described in the protocol)
• The participant is aged 18 to 55 years, inclusive, at the time of informed consent.
• The participant weighs at least 45 kilogram (kg) (99 pound [lb]) with a body mass index from 18 to 32 kilogram per square meter (kg/m^2) for healthy participants and up to 40.5 kg/m^2 for participants with schizophrenia, inclusive at screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception (as defined in the protocol)from signing of informed consent throughout the duration of the study and for 145 days have elapsed since the last dose of study drug.

Participants with schizophrenia only-:

• Is on a stable dose of an antipsychotic medication for at least 2 months as documented by medical history and assessed by site staff.
• Meets schizophrenia criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) by the Mini International Neuropsychiatric Interview (MINI).
• Has Positive and Negative Syndrome Scale (PANSS) total score less than or equal to ( =) 15 at screening and baseline (Day-1).
• Has stable screening and baseline (Day -1) PANSS and NSFS total scores (less than [ 450 millisecond (ms) or PR outside the range 120 to 220 ms, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
• The participant has abnormal Screening or Check-in laboratory values (> upper limit of normal [ULN] for the respective serum chemistries) of alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), ALP, gamma-glutamyl transpeptidase (GGT), 5'nucleotidase (Screening only) and/or abnormal urine osmolality, confirmed upon repeat testing.
• The participant has a clinically significant history of head injury or trauma associated with loss of consciousness for >15 minutes.
• Is considered by the investigator to be at an imminent risk of suicide injury to self, other, property, or participants who within the past year prior to Screening have attempted suicide. Participants having positive answer on item 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS) (based on the past year) prior to randomization are excluded.
• The participant has a history of significant skin reactions (hypersensitivity) to adhesives, metals or plastic; this criterion applies only to participants participating in the study of the two wearable digital devices.

Participants with schizophrenia only:

• Has an undetectable level of baseline antipsychotic medication at Screening.
• Has a lifetime diagnosis of schizoaffective disorder; a lifetime diagnosis of bipolar disorder; or a lifetime diagnosis of obsessive compulsive disorder based on the Mini International Neuropsychiatric Interview (MINI) combined with the general psychiatric evaluation. As an exception, participants with a historical prior lifetime diagnosis of schizoaffective disorder may be enrolled in the study with sponsor or designee approval provided that the principal investigator can attest that the participant's overall history and current clinical presentation and history is most consistent with schizophrenia, not schizoaffective disorder.
• Has a recent (within the last 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatri