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

NCT03150498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-24

No results posted yet for this study

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

DRUG

BTD-001

BTD-001 in fed vs fasted state

Sponsors & Collaborators

  • Balance Therapeutics

    lead INDUSTRY

Principal Investigators

  • Nand Signh, MD · Quotient Clinical Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2017-07-12
Completion
2017-07-12
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150498 on ClinicalTrials.gov