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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Combination product: RaniPill capsule containing octreotide

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous octreotide group; Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis	Combination product: RaniPill capsule containing octreotide; Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Experimental: RaniPill A group; In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis	Combination product: RaniPill capsule containing octreotide; Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Experimental: RaniPill B group; In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis	Combination product: RaniPill capsule containing octreotide; Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Experimental: RaniPill C group; In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug	Combination product: RaniPill capsule containing octreotide; Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and kind of adverse events possibly related to the RaniPill capsule	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	Up to 30 days after ingestion of the device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile of octreotide delivered by the RaniPill capsule	Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill	4 to 8 hours
Confirmation of the excretion of all RaniPill device components	Stool examinations to verify that all components of the RaniPill capsule have been defecated	up to 7 days

Collaborators and Investigators

• Sponsor: RANI Therapeutics
• Investigators: Study Director: Arvinder K Dhalla, PhD, RANI Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: RaniPill capsule, drug delivery, octreotide, pharmacokinetic
• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: TST-0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes