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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03798912
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : February 15, 2019
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 in healthy volunteers

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

Detailed Description:
The RaniPill 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) clinical, sequential design study in 10 healthy volunteers. In 5 subjects, octreotide (Sandostatin®) will be injected intravenously on a first study day, and a RaniPill containing octreotide will be administered on a second study day. In 5 other subjects, only the RaniPill containing octreotide will be administered. The bioavailability and pharmacokinetics of octreotide will be examined and compared by serial blood sampling, up to 4 h after its enteral versus intravenous administration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Sequential 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 RaniPillTM in Healthy Subjects
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intravenous octreotide and RaniPill
Octreotide 100 mcg will be injected intravenously and a RaniPill loaded with 100 mcg of octreotide will be administered
Combination Product: Intravenous octreotide and RaniPill
Intravenous injection of 100-mcg of octreotide on a first study day, and administration of a RaniPill 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.
Other Name: Sandostatin and RaniPill

Primary Outcome Measures :
  1. Incidence and kind of adverse events possibly related to the RaniPill [ Time Frame: Up to 7 days after ingestion of the device ]
    All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, and injuries to the gastrointestinal tract, will be monitored and recorded

Secondary Outcome Measures :
  1. Pharmacokinetic profile of octreotide delivered by the RaniPill [ Time Frame: 4 hours ]
    Measurements of octreotide concentration in plasma samples collected serially over 4 h following the ingestion of RaniPill

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.

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 identifier (NCT number): NCT03798912

Contact: Arvinder K Dhalla, PhD 4084573730
Contact: Rodolphe Ruffy, MD 4084573730

Sponsors and Collaborators
RANI Therapeutics
Nucleus Network Ltd
Study Director: Arvinder K Dhalla, PhD RANI Therapeutics at InCube Laboratories

Responsible Party: RANI Therapeutics Identifier: NCT03798912     History of Changes
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by RANI Therapeutics:
RaniPill, drug delivery, octreotide, pharmacokinetic

Additional relevant MeSH terms:
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents