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

NCT04240223 | Completed Phase 1 DMC

• 2 other identifiers: BC2502019-003367-22
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Site of release of radiolabel

  Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images

  To 14 hours post-dose

• Time to release of radiolabel

  Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images

  To 14 hours post-dose

• To visualise radiolabel dispersion within the colon

  To visualise the disintegration and dispersion of delayed release tablets from gamma scintigraphy images of the colon

  To 14 hours post-dose

Secondary Outcomes (8)

• Cmax

  To 24 hours post-dose

• Tmax

  To 24 hours post-dose

• Tlag

  To 24 hours post-dose

• AUClast

  To 24 hours post-dose

• AUC0-inf

  To 24 hours post-dose

Study Arms (6)

50 mg Brilacidin tablet

EXPERIMENTAL

Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA

100 mg Brilacidin tablet

EXPERIMENTAL

Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA

200 mg Brilacidin (2 x 100 mg Brilacidin tablets)

EXPERIMENTAL

Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA

Placebo tablet (replica of shape/size of 50 mg tablet)

PLACEBO COMPARATOR

Drug: Placebo; Radiation: 4Mq 99mTc-DTPA

Placebo tablet (replica of shape/size of 100 mg tablet)

PLACEBO COMPARATOR

Drug: Placebo; Radiation: 4Mq 99mTc-DTPA

Placebo (2 x replica of shape/size of 100 mg tablets)

PLACEBO COMPARATOR

Drug: Placebo; Radiation: 4Mq 99mTc-DTPA

Interventions

Brilacidin DRUG

Brilacidin

100 mg Brilacidin tablet; 200 mg Brilacidin (2 x 100 mg Brilacidin tablets); 50 mg Brilacidin tablet

Placebo DRUG

Placebo

Placebo (2 x replica of shape/size of 100 mg tablets); Placebo tablet (replica of shape/size of 100 mg tablet); Placebo tablet (replica of shape/size of 50 mg tablet)

4Mq 99mTc-DTPA RADIATION

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

100 mg Brilacidin tablet; 200 mg Brilacidin (2 x 100 mg Brilacidin tablets); 50 mg Brilacidin tablet; Placebo (2 x replica of shape/size of 100 mg tablets); Placebo tablet (replica of shape/size of 100 mg tablet); Placebo tablet (replica of shape/size of 50 mg tablet)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male volunteers.
• Aged between 18 and 65 years inclusive.
• BMI between 18 and 30 kg/m², inclusive. Body weight ≥50 kg.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities.
• Confirmed to be in general good health.

You may not qualify if:

• Medical History
• Current or recurrent disease that, in the opinion of the PMI or medically qualified designee/physician responsible, could affect the study conduct or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
• A history of current or relevant previous non self-limiting gastrointestinal disorders.
• Currently suffering from disease known to impact gastric emptying, e.g. migraine, Type 1 or Type 2 diabetes mellitus.
• Has untreated hypertension or has hypertension under treatment.
• Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
• As a result of physical examination or screening investigations, and available prior to dosing evaluations, the PMI or medically qualified designee/ physician responsible considers the volunteer unfit for the study.
• Medications
• Subject is scheduled to take prescribed medication within 14 days prior to the assessment visit.
• Subject is scheduled to take over-the-counter (OTC) medication, including vitamins and natural or herbal remedies, within 48 hours prior to the assessment visit.
• Alcohol/Substance Abuse
• Recent history (within the last year) of alcohol or other substance abuse.
• Subject has an average weekly alcohol intake of greater than 21 units.
• Subject has positive urine drugs of abuse test at screening or prior to dosing evaluation.

Sponsors & Collaborators

• Innovation Pharmaceuticals, Inc.: lead

Study Sites (1)

BDD Pharma Ltd

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Interventions

brilacidin

Study Officials

• Howard Stevens, PhD

  BDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: January 6, 2020
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)