Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

What Was Tested

This registered phase 1 trial tested Teriparatide.

It had five arms (groups): RT-102 Group 1 (experimental), RT-102 Group 2 (experimental), SC Group (active comparator), Part 2; Group 1 (experimental) and Part 2; Group 2 (experimental).

The registry classes the interventions as combination product and drug.

More on the Plan

The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall.

This is a single-center, prospective, open-label, feasibility study being conducted in two parts.

Who Took Part

The registry lists 50 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures. Willing to comply with all study procedures and available for the entire duration of the study. Participant is ambulatory female between 18 to 65 years of age. BMI between 19 to 32 kg/m2. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures.

The full record lists 17 inclusion and 67 exclusion criteria; among the exclusions: participant has known history of intolerance of pth (1-34); participant has known history of high levels of uric acid outside normal ranges; participant has known history of osteoporosis or other bone disorders (such as paget's disease).

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 Teriparatide study: the participants and staff both knew the treatment.

It started in 2022-02-21 with completion listed for 2022-10-10.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Evaluate Cmax of PTH administered via the RaniPill capsule (time frame: Within 24 hours after ingestion of the device). Evaluate Tmax of PTH administered via the RaniPill capsule (time frame: Within 24 hours after ingestion of the device). Evaluate AUC of PTH administered via the RaniPill capsule (time frame: Within 24 hours after ingestion of the device).

It also tracked 1 secondary outcome, for example Safety and tolerability of RT-102.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Teriparatide in 50 people.

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

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