Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A First-in-Human Study of Enteral Drug Delivery Device (RANIFIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03798912
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Nucleus Network Ltd
Information provided by (Responsible Party):
RANI Therapeutics

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Combination Product: Intravenous octreotide and RaniPill capsule Phase 1

Detailed Description:
The RaniPill device is an ingestible, capsule-like device, which, once in the jejunum, deploys and, via a microneedle, injects a microtablet (payload) into the intestinal wall. This is a phase I (first-in-human) open-label study in 46 healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. In 20 subjects a RaniPill capsule with a small balloon size (RaniPill A) containing 100 mcg of octreotide will be administered. In 20 other subjects a RaniPill capsule with a larger balloon size (RaniPill B) containing 100 mcg of octreotide will be administered. In each study group, the bioavailability and PK of octreotide will be examined by serial blood sampling after its enteral or intravenous administration.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy men and women volunteers
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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 : July 12, 2019
Actual Primary Completion Date : February 17, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine


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: Intravenous octreotide and RaniPill capsule
Intravenous injection of 100-mcg of octreotide on a first study day, and administration of a RaniPill capsule loaded with 100 mcg of octreotide on a second study day. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of the bioavailability of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Other Name: Sandostatin and 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: Intravenous octreotide and RaniPill capsule
Intravenous injection of 100-mcg of octreotide on a first study day, and administration of a RaniPill capsule loaded with 100 mcg of octreotide on a second study day. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of the bioavailability of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Other Name: Sandostatin and 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: Intravenous octreotide and RaniPill capsule
Intravenous injection of 100-mcg of octreotide on a first study day, and administration of a RaniPill capsule loaded with 100 mcg of octreotide on a second study day. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of the bioavailability of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Other Name: Sandostatin and RaniPill capsule




Primary Outcome Measures :
  1. Incidence and kind of adverse events possibly related to the RaniPill capsule [ Time Frame: 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 [ Time Frame: 4 to 8 hours ]
    Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill

  2. Measurement of the gastric emptying time [ Time Frame: 5 hours ]
    Measurement of the time between RaniPill capsule ingestion and entry into the small intestine

  3. Measurement of the intestinal deployment time [ Time Frame: 5 hours ]
    Measurement of the time between RaniPill capsule entry into the small intestine and RaniPill capsule deployment

  4. Confirmation of the excretion of all RaniPill device components [ Time Frame: up to 7 days ]
    Stool examinations to verify that all components of the RaniPill capsule have been defecated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798912


Locations
Layout table for location information
Australia
Alfred Hospital
Melbourne, Australia
Sponsors and Collaborators
RANI Therapeutics
Nucleus Network Ltd
Investigators
Layout table for investigator information
Study Director: Arvinder K Dhalla, PhD RANI Therapeutics at InCube Laboratories
Layout table for additonal information
Responsible Party: RANI Therapeutics
ClinicalTrials.gov Identifier: NCT03798912    
Other Study ID Numbers: TST-0114
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: 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:
Layout table for MeSH terms
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents