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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Food on the Pharmacokinetics of ORIC-114

NCT06012721

Food Effect in Healthy Participants

COMPLETED PHASE1

To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371

NCT02538003

Healthy

COMPLETED PHASE1

A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

NCT01820936

Healthy Volunteers

COMPLETED PHASE1

Food-Effect Pharmacokinetic Study of PL2200

NCT01244100

Healthy

COMPLETED PHASE1

Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules in Healthy Volunteers

NCT01408316

Healthy Volunteer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fed Cohort

PBT2 250 mg is administered orally following a high fat breakfast

Group Type OTHER

Fed Cohort PBT2

Intervention Type DRUG

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

Fasted Cohort

PBT2 250 mg is administered orally following a 10 hour period of fasting

Group Type OTHER

Fasted Cohort PBT2

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fed Cohort PBT2

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

Intervention Type DRUG

Fasted Cohort PBT2

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes