Status:
COMPLETED
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
Lead Sponsor:
RANI Therapeutics
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03798912
Start Date
July 9 2019
End Date
February 17 2020
Last Update
October 8 2020
Active Locations (1)
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1
Nucleus Network
Melbourne, Australia