The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
Nucleus Network
Melbourne, Australia
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
Time frame: Up to 30 days after ingestion of the device
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
Time frame: 4 to 8 hours
Confirmation of the excretion of all RaniPill device components
Stool examinations to verify that all components of the RaniPill capsule have been defecated
Time frame: up to 7 days
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