A Comparison Study of PF708 and Forteo in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Teriparatide.

It had two arms (groups): Sequence A (experimental) and Sequence B (experimental).

Single subcutaneous injection of two teriparatide products (PF708 and Forteo).

Single subcutaneous injection of two teriparatide products (Forteo and PF708).

The registry classes the interventions as drug.

More on the Plan

This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects.

Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Male or female aged 18-50 years at the time of Informed Consent. Able to understand and sign the written Informed Consent Form (ICF).

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study; history of paget's disease of bone; history of prior external beam or implant radiation therapy involving the skeleton.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Teriparatide and the comparison in turn, acting as their own control.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-12 with completion listed for 2016-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Serum area-under-the-curve (AUC) of PF708 and Forteo (time frame: 24 hours). Serum maximum concentration (Cmax) of PF708 and Forteo (time frame: 24 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teriparatide in 70 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.