Oral delivery of semaglutide to the colon Not Applicable
Conditions
Interventions
Treatment A: One radiolabelled Rybelsus® 7 mg semaglutide tablet (comparator)
Treatment B: Two radiolabelled 3.5 mg semaglutide EC OralogiKTM tablets (designed to release in the proximal colon)
Treatm
Sponsors
BDD Pharma Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Aged between 18 and 60 years inclusive 3. BMI between 18 and 30 kg/m², inclusive. Body weight =50 kg 4. Understands and is willing, able, and likely to comply with all study procedures including consumption of meals provided and restrictions 5. 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 6. Good general health with (in the opinion of the Principal Investigator (PI), or medically qualified designee) no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs, ECG and screening clinical laboratory results 7. Unless you have had a vasectomy more than 12 weeks prior to the study starting you must be willing to use a condom with spermicide or practice sexual abstinence with any male partner for the duration of the trial and for 90- days after the last assessment visit. Unless you have had a vasectomy more than 12 weeks prior to study starting you must be willing to abstain from sexual intercourse with women of childbearing potential for the duration of the trial and for 90 days after the last assessment visit OR agree to use a condom in addition to having your female partner use a form of hormonal contraception such as the oral contraceptive pill, implant, hormonal contraceptive injection or an intrauterine device (coil).
Exclusion criteria
Exclusion criteria: 1. Medical history: 1.1. Current or recurrent disease/condition that, in the opinion of the PI or medically qualified designee responsible, could affect study conduct; the safety of the subject as a result of participation; and/or the ability of the subject to complete the study or laboratory assessments. For example: hepatic disorders, renal insufficiency, congestive heart failure, conditions known to impact gastric emptying such as migraine or diabetes mellitus and relevant non-self-limiting GI disorders. 1.2. A history of acute pancreatitis regardless of aetiology 1.3. Family history of pancreatic cancer 1.4. Personal or family history of Multiple Endocrine Neoplasia type 2 or medullary thyroid tumour 1.5. Current or relevant previous history of serious, severe or unstable psychiatric illness, that may require treatment or make the subject unlikely to fully complete the study, or that presents undue risk from the study medication or procedures 1.6. History of previous surgical intervention which could affect GI transit and/or function for example gastric surgery, vagotomy or known adhesions with previous obstructive symptoms 1.7. Haematological or biochemical blood test at screening outside normal ranges and deemed clinically significant by the PI or medically qualified designee 1.8. Amylase and lipase values from blood tests outside normal ranges 1.9. Has a diagnosis of an immunosuppressive disorder or a condition requiring chronic immunosuppression 1.10. Any contraindication to the gamma scintigraphy procedure 1.11. As a result of a physical examination or screening investigations available prior to dosing evaluations, the PI or medically qualified designee/physician responsible considers the volunteer unfit for the study 1.12. Measured body temperature >38°C at screening visit (COVID-19 risk reduction procedure) 2. Medications: 2.1. Subject is scheduled to take prescribed medication within 14 days prior to the first or any subsequent assessment visit which, in the opinion of the PI or medically qualified designee responsible, will interfere with the study procedures or has the potential to affect gastric emptying and/or gut transit or compromise safety 2.2. Subject is scheduled to take over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to the first or any subsequent assessment visit 3. Alcohol/substance abuse: 3.1. Recent history (within the last year) of alcohol or other substance abuse 3.2. Subject has an average weekly alcohol intake of greater than 14 units 3.3. Subject has positive urine drugs of abuse test at screening or prior to dosing evaluation 3.4. Subject has a positive breath alcohol test at screening or prior to dosing evaluation 4. Smoking: 4.1. Subject has recently discontinued smoking (less than 3 months). 4.2. Subject is currently a smoker or user of nicotine-containing products 4.3. Subject has a positive urine cotinine test at screening or prior to dosing evaluation 5. Allergy/intolerance: 5.1. Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the PI or medically qualified designee responsible, contraindicates their participation 5.2. Subject has an allergy to any of the contents of the standardised meals 5.3. Subject is vegetarian or vegan 6. Clinical studies: 6.1. Participation in another clinical study (inclusive of final post-study examination) or receipt of an inves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance of two early prototype targeted release semaglutide formulations, using gamma scintigraphy to monitor their location in the gastrointestinal tract with time in the fasted state. Imaging carried out every 15 min until a maximum of 12 h post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The absorption of semaglutide in blood plasma from targeted release semaglutide formulations and scintigraphic data. Blood samples taken pre-dose and at specified intervals as follows: Treatment B: 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 16, 20 and 24 h; and Treatment C: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24 h 2. The pharmacokinetic profiles of the prototype formulations and Rybelsus® 7 mg Semaglutide tablet in the fasted state. Blood samples taken pre-dose and at specified intervals as follows: Treatment A: 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 h | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactLyn Corry
Outcome results
None listed