Phase 1 Completed N=18 Basic Science

Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine

Healthy Volunteers

Source: ClinicalTrials.gov NCT02109497 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg — 32775 ng*hr/mL

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.