At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
TAK-828 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Non-Japanese and Japanese Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-828 and Placebo for Dose Finding Study. Completed, enrolled 36 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDose Finding Study
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMar 2016
Primary CompletionJun 2016
TodayJul 2026
First PostedMar 11, 2016
Enrollment StartMar 1, 2016
Primary CompletionJun 17, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.3 years ago
Interventions
TAK-828drug
TAK-828 oral solution
Placebodrug
TAK-828 placebo-matching oral solution