A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001

Summary

This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001. Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001

Timeline

Start

2017-05-03

Primary completion

2017-07-12

Completion

2017-07-12

Drugs

Indications

No indication recorded.