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

Prana Biotechnology

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: PBT2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02109497

PBT2-104

Details and patient eligibility

About

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.

Full description

This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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