At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 86 enrolled
Drug / intervention
D5884 +1 moredrug
Likely dose
D5884 2gfrom 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 Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884
In Brief
A Phase 1 clinical trial evaluating D5884 and Placebo for Healthy. Completed, enrolled 86 participants across 1 site.
Detailed Summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartAug 2014
First PostedAug 2014
Primary CompletionNov 2014
TodayJul 2026
First PostedAug 6, 2014
Enrollment StartAug 1, 2014
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.9 years ago
Interventions
D5884drug
1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian
Placebodrug
1. st cohort: Dose 1(2g) D5884(n=3) in Japanese 2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese