At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Fed Cohort PBT2 +1 moredrug
Likely dose
Fed Cohort PBT2 250 mgfrom 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, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Fed Cohort PBT2 and Fasted Cohort PBT2 for Healthy Volunteers. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesAustralia
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionJun 2014
Study CompletionJul 2014
TodayJul 2026
First PostedApr 8, 2014
Enrollment StartMay 1, 2014
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.2 years ago
Interventions
Fed Cohort PBT2drug
PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
Fasted Cohort PBT2drug
PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food