Duodenal drug delivery Other
Conditions
Interventions
This is a non-CTIMP single centre, proof of concept, open-label, two arm, crossover study in up to 8 healthy male and female adult volunteers. This study will evaluate two novel drug delivery systems
Sponsors
BDD Pharma Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years 2. BMI between 18 and 32 kg/m², inclusive. 3. Understands and is willing, able, and likely to comply with all study procedures and restrictions. 4. 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. 5. Healthy (as determined by the PI or medically qualified designee) with 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. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator judges and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 6. Family Planning Male Participants: A male participant is eligible to participate if during the study intervention period and for at least 90 days after the last dose of study intervention: a) They agree to refrain from donating sperm PLUS, either: b) Are abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR c) Agree to use a male condom in addition to their female partner using an additional highly effective contraceptive method with a failure rate of < 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant Female Participants: A female participant is eligible to participate if during the study intervention and for at least until the follow up visit of the study: a) She is not pregnant or breastfeeding or expressing milk for human consumption AND b) She agrees to refrain from egg donation PLUS, either: c) She is of non-childbearing potential (WONCBP) as per CTCG definition OR d) Agrees to use a highly effective form of birth control preferably with low user dependency if sexually active with a fertile male partner
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 participant as a result of participation; and/or the ability of the participant 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. Current or relevant previous history of severe or unstable psychiatric illness, that may require treatment or make the participant unlikely to fully complete the study, or that presents undue risk from the study medication or procedures. 1.3. 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. 1.4.Haematological, biochemical or virology blood test at screening outside normal ranges and deemed clinically significant by the PI or medically qualified designee. 1.5.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. 1.6. Measured body temperature >38°C (at screening or assessment visits). 2. Medications 2.1. Participant is scheduled to take prescribed medication within 14 days (or 5 half-lives – whichever is longer) 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. Participant 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 unless approved by the PI or medically qualified designee. 3. Alcohol/Substance Abuse 3.1. Recent history (within the last year) of alcohol or other substance abuse in the opinion of the investigator (including alcohol and marijuana) within the last 2 years prior to informed consent, or a positive urinary drugs of abuse test at any of the defined points in the protocol. 3.2. Participant has an average weekly alcohol intake of greater than 14 units. 3.3. Participant has a positive breath alcohol test at screening or prior to dosing evaluation. (breath testing may be repeated once at investigator discretion within a 5 minute window of first test) 4. Smoking 4.1. Participant is currently a smoker or user of nicotine-containing products. 4.2. Participant has a positive urine cotinine test at screening or prior to dosing evaluation. 5. Allergy/Intolerance: Participant 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. 6. Clinical Studies 6.1. Participation in another clinical study (inclusive of the final post-study examination) of an investigational drug within the 12 weeks before screening visit, or five elimination half-lives of the previous study drug, whichever is longer. 6.2. Participant whose participation in this study will result in a participation in more than four studies over a twelve month period. 7. Personnel:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time and site of onset of radiolabel release measured using scintigraphic imaging at 5 minute intervals for up to 4 hours. Time will be recorded as the mid-point time between the image at which the endpoint is first observed and the previous image.;Time and site of completion of radiolabel release measured using scintigraphic imaging at 5 minute intervals for up to 4 hours. Time will be recorded as the mid-point time between the image at which the endpoint is first observed and the previous image.;Gastric emptying time of the tablet(s) measured using scintigraphic imaging at 5 minute intervals for up to 4 hours. Time will be recorded as the mid-point time between the image at which the endpoint is first observed and the previous image. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment emergent and serious adverse events reported following dosing measured using Adverse Event checks at hourly intervals until the participant departs from site | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactLyn;Alison Corry;McColl
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Outcome results
None listed