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

Healthy Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03150498
Study type Interventional
Source Balance Therapeutics
Contact
Status Completed
Phase Phase 1
Start date May 3, 2017
Completion date July 12, 2017
View Details
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