NCT04240223

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

A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Innovation Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Brilacidin is a fully synthetic, non-peptidic, host defense protein mimetic, and has been shown to demonstrate anti-inflammatory and antibacterial activities. Two prototype tablets have been developed to contain 50 mg or 100 mg of Brilacidin. Matching placebo tablets have also been developed. In this Phase 1 study, the delayed release prototype tablets will be tested to confirm efficient and specific target release of Brilacidin in the colon and to assess the safety, tolerability and the pharmacokinetics of Brilacidin administered directly to the colon. Three subjects will be enrolled into each cohort of the study. Each subject will receive one treatment at one Assessment Visit. In each cohort, two subjects will receive a Brilacidin containing dose, and one subject will receive placebo. Cohort 1: 50 mg Brilacidin or Placebo; Cohort 2: 100 mg Brilacidin or Placebo; Cohort 3: 200 mg Brilacidin (as 2 x 100 mg Brilacidin tablets) or 2 x Placebo. Each treatment (drug and placebo) will be radiolabelled with technetium-99m (99mTc). The radiopharmaceutical, 99mTc-DTPA, does not enter the systemic circulation and is routinely used for investigations of this type. In Cohort 1 and 2 each tablet, including placebo, will be radiolabelled to contain approximately 4 MBq 99mTc-DTPA at time of dosing. In Cohort 3 each individual tablet, active or placebo, will be radiolabelled with 2 MBq 99mTc-DTPA to give a total dose of 4 MBq per treatment. Each tablet will be taken orally with 200 mL room temperature water with subjects in the fasted state. The gastrointestinal transit and release behavior of the tablets will be studied using gamma scintigraphy. Blood samples will be taken at pre-defined times to allow pharmacokinetic (PK) evaluation of drug absorption with respect to time and location of tablet release.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2020-01-27
• Last updated: 2020-02-24

Locations

1 site across 1 country: United Kingdom