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

What Was Tested

The trial (phase 1) is built around Octreotide.

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

It had four arms (groups): Intravenous octreotide group (active comparator), RaniPill A group (experimental), RaniPill B group (experimental) and RaniPill C group (experimental).

In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis.

In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis.

The registry classes the interventions as combination product.

More on the Plan

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.

Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each).

The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B.

Who Took Part

The registry lists 62 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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;.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2019-07-09 with completion listed for 2020-02-17.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence and kind of adverse events possibly related to the RaniPill capsule (time frame: Up to 30 days after ingestion of the device).

It also tracked 2 secondary outcomes, for example Confirmation of the excretion of all RaniPill device components.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Octreotide in 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.