NCT03150498

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

A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Balance Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Food Effect
• Healthy

Interventions

Type	Name	Description
DRUG	BTD-001	BTD-001 in fed vs fasted state

Timeline

• Start date: 2017-05-03
• Primary completion: 2017-07-12
• Completion: 2017-07-12
• First posted: 2017-05-12
• Last updated: 2017-10-24

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study