A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform

A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects

The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.