Conditions: Healthy Volunteers
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: yes

Brief 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.

Detailed 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.

Arms:
arm 1: Single dose of caffeine 100 mg administered

Interventions: intervention 1: PBT2
Intervention descriptions: intervention 1: PBT2 250 mg administered

Protocol document: