Nasally and sc Administered Teriparatide in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Teriparatide.

Treating osteoporosis and the associated fractures costs the NHS more than two billion pounds per annum.

It had five arms (groups): Forsteo (active comparator), CP046 PTH CriticalSorb 22.5 R (experimental), CP046 PTH CriticalSorb 45.0 R (experimental), CP046 PTH CriticalSorb 90.0 R (experimental) and CP046 PTH CriticalSorb 90.0 O (experimental).

The registry classes the interventions as drug.

More on the Plan

This study aims to look at how teriparatide spreads through the nose and into the blood stream when it is given as a liquid with a nasal delivery system called CriticalSorb™.

For part of the study a radioactive compound (routinely used in the nuclear medicine clinic for diagnosis) will be added to the formulation in order to investigate how the formulation spreads through nose after it is sprayed.

The study is being carried out in postmenopausal females aged greater than 55 years of age as osteoporosis commonly affects these women.

The study will involve 8 visits.

Who Took Part

7 planned participants were the target.

It was open to women only aged from 55 years up to 90 years.

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

Examples of who could join: Be a postmenopausal healthy female and aged greater than 55 years of age. Be able to give voluntary informed consent and from whom written consent to participate has been obtained. Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments. Be willing to avoid caffeine from midnight the evening prior to each study day.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: have a history of alcohol or drug abuse and failure of urine tests for drug abuse; have had any investigational drug administered within the previous 3 months; failed to satisfy the investigator's assessment of fitness to participate based on a completed health screening.

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

Each person switched between Teriparatide and the comparison at some point, usually with a gap in between.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-09 with completion listed for 2014-08.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration. Peak plasma concentration (cmax) of teriparatide for six hours after each single administration.

It also tracked 1 secondary outcome, for example The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Teriparatide in 7 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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