Oral delivery of a vitamin formulation to the colo

Not Applicable

Completed

• Conditions: Oral delivery of vitamin formulation to the colon; Not Applicable

• Registration Number: ISRCTN60502217
• Lead Sponsor: BDD Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-19
• Study Completion: 2024-08-02
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Aged between 18 and 65 years inclusive.
2.1. BMI between 18 and 32 kg/m², inclusive.
2.2. Body weight =50 kg
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, in consultation with the Sponsor if required, judges and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
6. Family Planning:
Females must be the following:
Compliant with highly effective methods of contraception as described in section 10.4 (Appendix 4) if they have a fertile male partner.
OR
Of non-reproductive potential defined as:
Pre-menopausal females with one of the following:
Documented tubal ligation.
Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
Hysterectomy
Documented Bilateral Oophorectomy
Documented Postmenopausal defined as 12 months of spontaneous amenorrhea
Partners of male participants of childbearing potential or must be compliant with highly effective methods of contraception

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 or biochemical blood test at screening or repeat eligibility testing outside normal ranges and deemed clinically significant by the PI or medically qualified designee. Note: In case of abnormal laboratory values that could indicate a temporary condition, the test can be performed again once before enrolment.
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 at assessment visit
2. Medications
2.1.Participant is scheduled to take prescribed non-permitted 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.
3.2.Participant has an average weekly alcohol intake of greater than 14 units.
3.3.Participant has positive urine drugs of abuse test at screening or prior to dosing evaluation.
3.4.Participant has a positive breath alcohol test at screening or prior to dosing evaluation.
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
5.1.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.
5.2.Participant has an allergy to any of the contents of the standardised meals.
5.3.Participant is vegetarian or vegan.
6. Clinical Studies
6.1.Participation in another clinical study with an investigational drug (inclusive of final post-study examination) or receipt 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Site and time of onset of disintegration of the novel vitamin tablet formulation using gamma scintigraphy. Imaging carried out every 15 minutes until a maximum of 14 h post dose.

Secondary Outcome Measures

Name	Time	Method
1. Safety and tolerability of the novel vitamin tablet formulation:<br>1.1. Safety bloods and urinalysis will be checked at screening and follow up<br>1.2. Vital signs will be checked at screening, assessment visit and follow up<br>1.3. Hourly adverse events checks will be conducted from dosing until completion of the assessment visit<br>2. Gastrointestinal transit parameters of the novel vitamin tablet formulation using gamma scintigraphy. Imaging carried out every 15 minutes until a maximum of 14 h post dose<br>3. To assess site and time of complete disintegration of the novel vitamin tablet formulation using gamma scintigraphy. Imaging carried out every 15 minutes until a maximum of 14 h post dose.