ISRCTN60502217已完成Unknown
A proof of concept scintigraphic study to investigate the in vivo performance of an orally delivered colon targeted vitamin formulation in healthy volunteers
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •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
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