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

Healthy Volunteers Clinical Trial

— RaniPill  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798912
• Other study ID #: TST-0114
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2019
• Est. completion date: February 17, 2020

Study information

• Verified date: October 2020
• Source: RANI Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
RANI Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic profile of octreotide delivered by the RaniPill capsule	Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill	4 to 8 hours
Secondary	Confirmation of the excretion of all RaniPill device components	Stool examinations to verify that all components of the RaniPill capsule have been defecated	up to 7 days