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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

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE January 10, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
Blood concentrations of octreotide after ingestion of the RaniPill [ Time Frame: Within 24 hours after ingestion of the device ]
Measurements of octreotide in plasma samples collected serially over 24 h following the ingestion of RaniPill
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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
  • Measurement of the gastric emptying time [ Time Frame: 5 hours ]
    Measurement of the time between RaniPill capsule ingestion and entry into the small intestine
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
Possible adverse effects caused by the RaniPill [ Time Frame: Within 24 hours after ingestion of the device ]
Monitoring and recording of adverse events possibly related to the device
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First-in-Human Study of Enteral Drug Delivery Device
Official Title  ICMJE A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
Brief Summary The objective of this study is to ascertain the efficacy and short-term safety of the RaniPill capsule in healthy volunteers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Healthy men and women volunteers
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Intravenous octreotide group
    Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis
    Intervention: Combination Product: Intravenous octreotide 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
    Intervention: Combination Product: Intravenous octreotide 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
    Intervention: Combination Product: Intravenous octreotide and RaniPill capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2020)
62
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
10
Actual Study Completion Date  ICMJE February 17, 2020
Actual Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03798912
Other Study ID Numbers  ICMJE TST-0114
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RANI Therapeutics
Study Sponsor  ICMJE RANI Therapeutics
Collaborators  ICMJE Nucleus Network Ltd
Investigators  ICMJE
Study Director: Arvinder K Dhalla, PhD RANI Therapeutics at InCube Laboratories
PRS Account RANI Therapeutics
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP