A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults

What Was Tested

In this phase 1 trial, researchers set out to test Parathyroid Hormone (PTH 1-84).

Bioavailability is the ability of a drug to be absorbed and used by the body.

It had six arms (groups): Part I: Sequence AB (experimental), Part I: Sequence BA (experimental), Part II: Sequence CDEF (experimental), Part II: Sequence DFCE (experimental) and Part II: Sequence ECFD (experimental).

The registry classes the interventions as drug.

More on the Plan

This study will be conducted in two parts (Part I and Part II).

Part I consists of two treatment periods with 2 sequences and part II consists of four treatment periods with 4 sequences.

Both parts may be conducted concurrently.

Who Took Part

96 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: positive urine drug or alcohol results at screening or check-in; history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds; history of abnormalities of calcium homeostasis including hyperparathyroidism, hypoparathyroidism, hyperthyroidism, cushing's syndrome, hypercalcemia, hypocalcemia, osteoporosis, or any other calcium disorder.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Parathyroid Hormone (PTH 1-84) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Parathyroid Hormone (PTH 1-84) and the comparison in turn, acting as their own control.

Being open-label, the Parathyroid Hormone (PTH 1-84) study did not mask who received what.

It started in 2021-11-29 with completion listed for 2022-04-15.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84). Part II: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84). Part I: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84).

It also tracked 3 secondary outcomes, for example Part I and II: Number of Participants With Treatment Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Parathyroid Hormone (PTH 1-84) in 96 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.