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

Rani Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Combination Product: RaniPill capsule containing octreotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03798912

TST-0114

Details and patient eligibility

About

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

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups

Intravenous octreotide group

Active Comparator group

Description:

Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis

Treatment:

Combination Product: RaniPill capsule containing octreotide

RaniPill A group

Experimental group

Description:

In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis

Treatment:

Combination Product: RaniPill capsule containing octreotide

RaniPill B group

Experimental group

Description:

In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis

Treatment:

Combination Product: RaniPill capsule containing octreotide

RaniPill C group

Experimental group

Description:

In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug

Treatment:

Combination Product: RaniPill capsule containing octreotide