A First-in-Human Study of Enteral Drug Delivery Device

• Status: Not yet recruiting
• Trial end date: 2019-07-01
• Target enrollment: 10
• Participant gender: All

Summary

The objective of this study is to ascertain the efficacy and short-term safety of the RaniPill in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RANI Therapeutics
• Collaborator: Nucleus Network Ltd
• Treatments: Octreotide

Criteria

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 20 and 50 years

• BMI <28;

• 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.