NCT02109497

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

A Phase 1, Single Centre, Open Label, Two-period Study in Healthy Volunteers to Determine the Effect of PBT2 on the Pharmacokinetics of Caffeine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Prana Biotechnology Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PBT2	PBT2 250 mg administered

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-04-10
• Last updated: 2016-04-29
• Results posted: 2016-04-29

Locations

1 site across 1 country: Australia