Healthy VolunteersPhase 1NCT04240223
A Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers
A Phase 1 study testing Brilacidin and 4Mq 99mTc-DTPA in people with Healthy Volunteers, run by Innovation Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brilacidin and 4Mq 99mTc-DTPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 12 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 39Show fewer
- 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.
- Subject has a positive breath alcohol test at screening or prior to dosing evaluation.
- Smoking
- Subject has recently discontinued smoking (less than 3 months).
- Subject is currently a smoker or user of nicotine-containing products.
- Subject has a positive urine cotinine test at screening or prior to dosing evaluation.
- Allergy/Intolerance
- Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the PMI or medically qualified designee/ physician responsible, contraindicates their participation.
- Has known allergies or intolerance to Brilacidin.
- Has an allergy to any of the contents of the standardised meals.
- Vegetarian or vegan.
- Suspected or diagnosed lactose intolerance.
- Clinical Studies
- Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before first screening visit.
- Previous participation in this study.
- Subject whose participation in this study will result in a participation in more than four studies over a twelve month period.
- Personnel; An employee of the Sponsor, client or study site or members of their immediate family.
- Radiation Exposure; Subject has a total dosimetry value which, in the opinion of the PMI or medically qualified designee/ physician responsible, contraindicates their participation.
- Blood
- Blood donation or significant blood loss within 3 months of screening.
- Difficulty accessing forearm veins for cannulation or blood sampling.
- Family Planning
- Subjects who are intending to father a child in the 90 days following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women.
- Subjects who are unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the assessment visit until 3 months following the study.
- Other; Non-removable metal objects such as metal plates, screws etc in their chest or abdominal area which in the opinion of the PMI or medically qualified designee/ responsible physician could affect the study conduct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers
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.
Read the 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
- Being tested
- Brilacidin, Placebo, 4Mq 99mTc-DTPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrilacidinDrug
Brilacidin
PlaceboDrug
Placebo
4Mq 99mTc-DTPARadiation
4Mq technetium-99m (99mTc), complexed with diethylenetriaminepentaacetic acid (DTPA) which prevents absorption of the radioisotope from the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| 50 mg Brilacidin tablet | Experimental | Not described Receives: Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA |
| 100 mg Brilacidin tablet | Experimental | Not described Receives: Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA |
| 200 mg Brilacidin (2 x 100 mg Brilacidin tablets) | Experimental | Not described Receives: Drug: Brilacidin; Radiation: 4Mq 99mTc-DTPA |
| Placebo tablet (replica of shape/size of 50 mg tablet) | Placebo comparator | Not described Receives: Drug: Placebo; Radiation: 4Mq 99mTc-DTPA |
| Placebo tablet (replica of shape/size of 100 mg tablet) | Placebo comparator | Not described Receives: Drug: Placebo; Radiation: 4Mq 99mTc-DTPA |
| Placebo (2 x replica of shape/size of 100 mg tablets) | Placebo comparator | Not described Receives: Drug: Placebo; Radiation: 4Mq 99mTc-DTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Site of release of radiolabel
Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images
Measured: 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
Measured: 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
Measured: To 14 hours post-dose
Secondary outcomes (8)
Cmax
Maximum Plasma Concentration
Measured: To 24 hours post-dose
Tmax
Time of Maximum Plasma Concentration
Measured: To 24 hours post-dose
Tlag
Lag Time
Measured: To 24 hours post-dose
AUClast
Area Under the Curve from time 0 to 24 hours
Measured: To 24 hours post-dose
AUC0-inf
Area Under the Curve from time 0 to infinity
Measured: To 24 hours post-dose
K
Terminal First Order Rate constant
Measured: To 24 hours post-dose
t1/2
Half Life
Measured: To 24 hours post-dose
Adverse Events
Number of Participants With Treatment-Emergent Adverse Events
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start6 Jan 2020
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Stevens, PhD, Principal investigator, BDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240223
- Sponsor's protocol ID
- BC250
- Other IDs
- 2019-003367-22, 2019
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04240223
- Acronym / sponsor ID
- BC250
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Innovation Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (39 listed)
- Medical History
- Medications
- Alcohol/Substance Abuse
- Smoking
- Allergy/Intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrilacidinBrilacidin | Drug | 100 mg Brilacidin tablet, 200 mg Brilacidin (2 x 100 mg Brilacidin tablets), 50 mg Brilacidin tablet |
| PlaceboPlacebo | Drug | 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-DTPA4Mq technetium-99m (99mTc), complexed with diethylenetriaminepentaacetic acid (DTPA) which prevents absorption of the radioisotope from the gastrointestinal tract | Radiation | 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) |
Primary outcome
Site of release of radiolabel
Time frame: To 14 hours post-dose
Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images
Time to release of radiolabel
Time frame: To 14 hours post-dose
Site of release of radiolabel determined by a qualified assessor based on gamma scintigraphy images
To visualise radiolabel dispersion within the colon
Time frame: To 14 hours post-dose
To visualise the disintegration and dispersion of delayed release tablets from gamma scintigraphy images of the colon
8 secondary outcomes
Cmax
Time frame: To 24 hours post-dose
Tmax
Time frame: To 24 hours post-dose
Tlag
Time frame: To 24 hours post-dose
AUClast
Time frame: To 24 hours post-dose
AUC0-inf
Time frame: To 24 hours post-dose
K
Time frame: To 24 hours post-dose
t1/2
Time frame: To 24 hours post-dose
Adverse Events
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Stevens, PhD principal investigator
BDD Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brilacidin and 4Mq 99mTc-DTPA in people with Healthy Volunteers, run by Innovation Pharmaceuticals, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Site of release of radiolabel (time frame: To 14 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.