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

NCT02107313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-03-30

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Fed Cohort PBT2

PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.

DRUG

Fasted Cohort PBT2

PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food

Sponsors & Collaborators

  • Prana Biotechnology Limited

    lead INDUSTRY

Principal Investigators

  • Caroline Herd · Prana Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107313 on ClinicalTrials.gov