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

Sponsor
RANI Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03798912
Collaborator
(none)
62
Enrollment
1
Location
4
Arms
7.3
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: RaniPill capsule containing octreotide
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Healthy men and women volunteersHealthy men and women volunteers
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
Actual Study Start Date :
Jul 9, 2019
Actual Primary Completion Date :
Feb 17, 2020
Actual Study Completion Date :
Feb 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence and kind of adverse events possibly related to the RaniPill capsule [Up to 30 days after ingestion of the device]

    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

Secondary Outcome Measures

  1. Pharmacokinetic profile of octreotide delivered by the RaniPill capsule [4 to 8 hours]

    Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill

  2. Confirmation of the excretion of all RaniPill device components [up to 7 days]

    Stool examinations to verify that all components of the RaniPill capsule have been defecated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nucleus Network Melbourne Australia

Sponsors and Collaborators

  • RANI Therapeutics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RANI Therapeutics
ClinicalTrials.gov Identifier:
NCT03798912
Other Study ID Numbers:
  • TST-0114
First Posted:
Jan 10, 2019
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by RANI Therapeutics
RaniPill capsule, drug delivery, octreotide, pharmacokinetic
Additional relevant MeSH terms:
Octreotide

Study Results

No Results Posted as of Oct 8, 2020