The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.
The drug being tested in this study is TAK-058, which is under evaluation for the treatment of schizophrenia. This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Cohort 1 Non-elderly Healthy: TAK-058 25 mg * Cohort 2 Non-elderly Healthy: TAK-058 75 mg * Cohort 3 Non-elderly Healthy: TAK-058 150 mg * Cohort 4 Elderly Healthy: TAK-058 25 mg * Cohort 5 Non-elderly Healthy: TAK-058 300 mg * Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that looks like the study drug but has no active ingredient. * Cohort 5 Elderly Placebo This single-center trial will be conducted in the United States. The overall time to participate in this study is 40 days if assigned to Cohort 1 to 4. Participants will be confined to the clinic for 12 days, and will be contacted by telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days 21 and 40). The overall time to participate in this study is 14 days if assigned to Cohort 5. Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment (Day 14).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
TAK-058 Solution
TAK-058 placebo-matching solution
Unnamed facility
Austsitn, Texas, United States
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.
Time frame: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Mean Cmax: Maximum Observed Plasma Concentration for TAK-058
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose
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Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058
AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.
Time frame: Day 1 predose and at multiple time points (up to 72 hours) postdose
Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058
AUC24 is measure of area under the curve from time 0 to 24 hours postdose.
Time frame: Day 1 predose and at multiple time points (up to 24 hours) postdose
Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058
Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.
Time frame: Day 10 predose and at multiple time points (up to 24 hours) postdose