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A Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers

NCT04240223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-02-24

No results posted yet for this study

Summary

This is a single-centre, blinded, randomized, placebo controlled, dose escalation study. Up to 9 healthy male volunteers will participate in the study. This study is designed to investigate the use of delayed release tablets for colonic delivery of Brilacidin.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Brilacidin

Brilacidin

DRUG

Placebo

Placebo

RADIATION

4Mq 99mTc-DTPA

4Mq technetium-99m (99mTc), complexed with diethylenetriaminepentaacetic acid (DTPA) which prevents absorption of the radioisotope from the gastrointestinal tract

Sponsors & Collaborators

  • Innovation Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Stevens, PhD · BDD Pharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04240223 on ClinicalTrials.gov