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A study investigating the use of delayed-release tablets to deliver brilacidin to the colon in healthy volunteers
Phase 1 Single Dose Escalation Study to Study the Use of Delayed-Release Tablets to Deliver Brilacidin to the Colon in Healthy Volunteers
Sponsors
Lead Sponsor: Innovation Pharmaceuticals, Inc.
A source Innovation Pharmaceuticals, Inc.
Summary
This is a single-center, blinded, randomized, placebo-controlled dose escalation study. Up to 9 healthy male volunteers will take part in the study. This study is intended to investigate the use of delayed-release tablets to deliver brilacidin to the colon.
Detailed description
Brilacidin is a fully synthetic non-peptide host defense protein mimetic that has been shown to exhibit anti-inflammatory and antibacterial activity. Two prototype tablets were developed containing 50 or 100 mg of brilacidin. Compliance Placebo pills have also been developed. In this phase 1 delayed-release study, prototype tablets will be tested to confirm the effective and specific targeted release of Brilacidin in the colon and to assess the safety, tolerability and pharmacokinetics of Brilacidin is administered directly to the Colon. Each study cohort will include three subjects. Each subject will receive one treatment at one assessment visit. In each cohort, two patients will receive brilacidin. containing a dose and one subject will receive a placebo. Cohort 1: brilacidin 50 mg or placebo; Cohort 2: 100 mg brilacidin or placebo; Cohort 3: Brilacidin 200 mg (as 2 100 mg brilacidin tablets) or 2 x placebo. Each treatment (drug and placebo) will be labeled with the radioactive isotope technetium-99m (99mTc). The radiopharmaceutical 99mTc-DTPA does not enter the systemic circulation and is commonly used for this type of research. In cohorts 1 and 2, each tablet, including placebo, will be radioactively labeled and contain approximately 4 MBq of 99mTc-DTPA at the time of dosing. In cohort 3, each individual tablet, active or placebo, will be radiolabeled with 2 MBq of 99mTc-DTPA for a total dose of 4 MBq per treatment. Each tablet should be taken orally with 200 ml of room temperature water. hungry state. Gastrointestinal transit and release of tablets will be investigated by gamma scintigraphy. Blood samples will be taken at a predetermined time to allow a pharmacokinetic (PK) assessment of drug absorption versus the time and place of tablet release.
General status Completed
the date of the beginning January 6, 2020
Date of completion 12 February 2020
Date of initial completion 12 February 2020
Phase Phase 1
Study type Interventional
Primary outcome
Measure Time limit
Radioactive label release site 14 hours after dosing
Time of release of the radioactive label 14 hours after dosing
To visualize the dispersion of the radioactive label in the colon 14 hours after dosing
Secondary result
Measure Time limit
Cmax 24 hours after dosing
Tmax 24 hours after dosing
Tlag 24 hours after dosing
AUClast 24 hours after dosing
AUC0-inf 24 hours after dosing
K 24 hours after dosing
t1 / 2 24 hours after dosing
Adverse events 14 days
check in 9
condition
Healthy volunteers
Intervention
Type of intervention: Drug, remedy, medication
Intervention Name: Brilacidin
Description: Brilacidin
Type of intervention: Drug, remedy, medication
Intervention Name: Placebo
Description: Placebo
Intervention Type: Radiation
Intervention name: 4Mq 99mTc-DTPA
Description: 4Mq technetium-99m (99mTc) in combination with diethylenetriaminepentaacetic acid (DTPA), which prevents absorption of the radioisotope from the gastrointestinal tract
Acceptability
Criteria:
Inclusion criteria: 1. Healthy male volunteers. 2. Age from 18 to 65 years inclusive. 3.BMI from 18 to 30 kg / m² inclusive. Body weight ≥50 kg. 4. Understands and is willing to, can and can comply with all research procedures and restrictions. 5. Demonstrates an understanding of the research and a willingness to participate, as evidenced by voluntary written informed consent (signed and dated) obtained prior to any judicial activity. 6. Confirmed to be in good health. Exclusion Criteria: 1.Medicine history 1.Current or recurrent medical condition that the PMI or a medically qualified authorized / responsible physician believes may affect the study or laboratory findings (e.g. liver dysfunction, renal failure, congestive heart failure). 2. a current or relevant previous history of a serious, severe, or unstable physical or mental illness, any medical condition that may require treatment or the subject is unlikely to complete the study, or any condition that poses an undue risk from the study drug or procedures. 3. a history of current or relevant previous non-self-limiting gastrointestinal disorder. 4. is currently suffering from a medical condition known to affect gastric emptying, such as migraines, type 1 or type 2 diabetes. 5. Has untreated hypertension or is being treated for hypertension. 6. Has a diagnosis of immunosuppressive disease or a condition requiring chronic immunosuppression. 7.As a result of medical examination or screening tests and is available before the dosage assessment, The PMI or the accredited / medically qualified physician in charge considers the volunteer unsuitable for research. 2. Medication 1. Subject must take prescribed medication within 14 days prior to assessment visit. 2. Subject must take over-the-counter medications, including vitamins and natural or herbal remedies, for 48 hours prior to evaluation visit. 3. Alcohol / Substance Abuse 1. A recent history (within the last year) of alcohol or other substance abuse. 2. The subject consumes on average over 21 units of alcohol per week. 3. At screening or pre-dosing, the subject tested positive for drug abuse in urine. appraisal. 4. Subject tested positive for alcohol breath at screening or pre-dose assessment. four. Smoking 1. Subject has recently quit smoking (less than 3 months). 2. The subject is currently smoking or consuming nicotine-containing products. 3. At screening or before dosing, the subject tested positive for cotinine in urine. appraisal. 5. Allergy / Intolerance 1. Subject has a history of allergy to any component of the dosage form or any other allergy that, in the opinion of PMI or the Medically Approved / Physician Responsible, is contraindicated. 2.Has an allergy or intolerance to brilacidin. 3. Is allergic to any content of standard meals. 4. Vegetarian or vegan. 5. Suspected or diagnosed lactose intolerance. 6.clinical research 1. participating in another clinical study (including a final post-study survey) or receiving an investigational drug within 12 weeks prior to the first screening visit. 2. Previous participation in this study. 3. A subject whose participation in this study will lead to participation in more than four studies within twelve months. 7. Personnel; An employee of the Sponsor, client or training center or members of their immediate family. 8. radiation exposure; The subject has an overall dosimetry value that the PMI or the responsible commissioner / medically qualified physician believes would contraindicate their involvement. 9. blood 1. Blood donation or significant blood loss within 3 months after the examination. 2. Difficulty accessing the veins of the forearm for cannulation or blood collection. 10. Family planning 1. Subjects who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ... who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ... who intend to father a child within 90 days of the study or who do not wish to abstain from sex with pregnant or lactating women. 2. Subjects who are unwilling to use a condom / spermicide in addition to their partner uses another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subcutaneous implants or tubal ligation if the woman can become pregnant from the moment examination visit up to 3 months after the examination. 11. Other; Non-removable metal objects such as metal plates, screws, etc. In the chest or abdomen that the PMI or the Medically Qualified Designator / Physician in charge believes may affect the study. ...
Gender: male
Gender: yes
Minimum age: 18 years
Maximum age: 65 years
Healthy Volunteers: Accepts Healthy Volunteers
General Official
Surname Role Accession
Howard Stevens, PhD Principal investigator BDD Pharma Ltd
Location
An object: BDD Pharma Ltd
Country Location
United Kingdom
Check date
February 2020
Responsible Party
Type: Sponsor
Has extended access Not
Number of hands 6
Armament group
Label: Brilacidin 50 mg tablet
Type: Experimental
Label: Brilacidin 100 mg tablet
Type: Experimental
Label: 200 mg brilacidin (2 tablets of brilacidin 100 mg)
Type: Experimental
Label: Placebo tablet (50 mg tablet shape / size copy)
Type: Placebo Comparator
Label: Placebo tablet (copy of 100 mg tablet shape / size)
Type: Placebo Comparator
Label: Placebo (2 copies of the shape / size of 100 mg tablets)
Type: Placebo Comparator
Patient data Not
Study Design Information
Distribution: Randomized
Intervention Model: Sequential Assignment
Primary Use: Other
Disguise: Single (member)
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