NCT03798912

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

A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: RANI Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2020-02-17
• Completion: 2020-02-17
• First posted: 2019-01-10
• Last updated: 2020-10-08

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study