A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence and kind of adverse events possibly related to the RaniPill capsule
研究概览
简要总结
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
详细描述
The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent form
- •Willing to comply with all study procedures and available for the entire duration of the study
- •Age between 18 and 55 years
- •BMI 17 - 32 kg/m2
- •In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per investigator's judgment;
- •Women of reproductive potential must use, between study day and the final study visit, a highly effective contraceptive, as defined in the Informed Consent Document, and have a negative urine pregnancy test at the time of screening, as well as on the day of study.
排除标准
- •Unable to swallow an intact 000 capsule with water
- •History of gastrointestinal surgery or illness, including diarrhea, constipation or other manifestations suggestive of abnormal digestion
- •Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5 days of study day
- •Barium ingestion within 30 days of study day
- •Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex
- •History chronic disease other than mild to moderate systemic hypertension
- •Menstruation on day of dosing
- •Pregnancy or lactating state
- •Participation in an investigational or marketed drug trial within 30 days of the screening visit
- •Low likelihood, in the investigator's judgment, to complete the study as required per study plan;
- •Any other history which, in the investigator's judgment, makes the subject ineligible or exposes the subject to a risk;
- •History of allergic reactions to a component of the RaniPill device or any allergic history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;
- •Febrile illness within 5 days;
- •History of drug or alcohol abuse or any other factor that, in the investigator's opinion, may interfere with the subject's ability to cooperate and comply with the study procedures.
结局指标
主要结局
Incidence and kind of adverse events possibly related to the RaniPill capsule
时间窗: Up to 30 days after ingestion of the device
All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded
次要结局
- Pharmacokinetic profile of octreotide delivered by the RaniPill capsule(4 to 8 hours)
- Confirmation of the excretion of all RaniPill device components(up to 7 days)