A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants

Phase 1

Terminated

Brief Summary: The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.

Detailed Description: The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy non-Japanese and Japanese participants in Parts 1 and 2, respectively.

The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TAK-828 or matching placebo. This assignment will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Proposed doses:

* Part 1: TAK-828 15 mg, 45 mg, 75 mg, 100 mg, and placebo twice daily

* Part 2: TAK-828 45 mg, and 100 mg, and placebo twice daily

All participants will be asked to take the solution at the same time each day throughout the study.

This multi-center trial will be conducted in the United States.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Part 1: Placebo	Placebo	TAK-828 placebo-matching solution, orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.
Part 2: Placebo	Placebo	TAK-828 placebo-matching solution, orally, twice daily on Days 1-14 in healthy Japanese participants.
Part 1: TAK-828 15 milligram (mg)	TAK-828	TAK-828 15 mg, solution (0.2 milligram per milliliter \[mg/mL\] or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.
Part 1: TAK-828 45 mg	TAK-828	TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.
Part 1: TAK-828 75 mg	TAK-828	TAK-828 75 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.
Part 1: TAK-828 100 mg	TAK-828	TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy non-Japanese participants.
Part 2: TAK-828 45 mg	TAK-828	TAK-828 45 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants.
Part 2: TAK-828 100 mg	TAK-828	TAK-828 100 mg, solution (0.2 mg/mL or 5 mg/mL), orally, twice daily on Days 1-13, and once on the morning of Day 14 in healthy Japanese participants.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)	Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)	Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose	Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose	Baseline up to 10 days after last dose of study drug (Day 24)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose	Baseline up to 10 days after last dose of study drug (Day 24)

Secondary Outcome Measures

Name	Time	Method
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)	Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F	Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F	Cohorts 1 and 2: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohort 3: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose