Phase 1
N=18
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02107313 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Area Under the Concentration-Time Curve (AUC 0-t) — 1490.0; 1273.0 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Fed Cohort PBT2 (Drug); Fasted Cohort PBT2 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prana Biotechnology Limited
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve (AUC 0-t) |
1490.0; 1273.0 | — |
| SECONDARY Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events |
6; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male or females with a BMI between 19 and 30kg/m2
- No clinically significant abnormalities
Exclusion Criteria
- Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
- Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
- Significant history of depression or other psychiatric illness
- Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
- unable to swallow capsules
Data sourced from ClinicalTrials.gov (NCT02107313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.