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

NCT03798912 | Completed Phase 1 FDA Device

• 1 other identifier: TST-0114
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

RaniPill capsule, drug delivery, octreotide, pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

Intravenous octreotide group

ACTIVE COMPARATOR

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

Combination Product: RaniPill capsule containing octreotide

RaniPill A group

EXPERIMENTAL

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

RaniPill B group

EXPERIMENTAL

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

RaniPill C group

EXPERIMENTAL

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

Interventions

RaniPill capsule containing octreotide COMBINATION_PRODUCT

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.

Intravenous octreotide group; RaniPill A group; RaniPill B group; RaniPill C group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RANI Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

Study Officials

• Arvinder K Dhalla, PhD

  RANI Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy men and women volunteers

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: January 10, 2019
• Study Start: July 9, 2019
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)