The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants.
The drug being tested in this study is called TAK-988. TAK-988 is being tested to evaluate safety, tolerability, PK, and PD of single and multiple oral doses in healthy non-Japanese and Japanese adult participants and HE participants. The study will enroll approximately 156 healthy participants. The study consists of 5 parts and up to 19 cohorts as mentioned below: * TAK-988, Part A: Single-rising dose (SRD) design to assess the safety, tolerability, and PK of TAK-988 and effect of food on the PK of the TAK-988 * TAK-988, Part B: MRD design to assess the safety, tolerability, PK and PD of TAK-988 * TAK-988, Part C: MRD design to assess the safety, tolerability, PK and PD of TAK-988 and also central nervous system penetration relative to plasma concentrations of TAK-988 * TAK-988, Part D: MRD design to assess the safety, tolerability, PK and PD of TAK-988 for HE participants * TAK-988, Part E: SRD and MRD design to assess the safety, tolerability, PK and PD of TAK-988 for Japanese origin participants Participants in each cohort will be randomized to receive treatment with TAK-988 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10.5 months. Participants will make a final visit 7 days after receiving their last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
TAK-988 tablets.
TAK-988 placebo-matching tablets.
Parexel Internalional - Glendale
Glendale, California, United States
PRA Health Sciences - Salt Lake City
Millcreek, Utah, United States
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 26
Number of Participants With at Least one Markedly Abnormal Value (MAV) for Laboratory Values
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Vital Signs
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Electrocardiograms (ECGs)
Time frame: Baseline up to Day 26
Cmax: Maximum Observed Plasma Concentration for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-988
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Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
CLR: Renal Clearance for TAK-988
Time frame: Day 1 (Parts A, B, D and E), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to tau over Dosing Interval for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Part C: Ratio of the Cerebrospinal Fluid (CSF) to Plasma AUC From Time 0 to 24 Hours for TAK-988
Time frame: Day 7 (Part C) Pre-dose and at multiple time points (up to 24 hours) post-dose
Rac (AUC): Accumulation Ratio Based on AUCτ for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose