Phase 1
N=18
Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02109497 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg — 32775 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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 Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg |
32775 | — |
| SECONDARY Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event |
7 | — |
Summary
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.
Eligibility Criteria
Inclusion Criteria
- Healthy males 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
- 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 or tablets
Data sourced from ClinicalTrials.gov (NCT02109497). 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.