Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects

What Was Tested

The trial (phase 1) is built around Parathyroid Hormone (PTH 1-84).

The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy adults of Japanese descent and matched, healthy Caucasian adults.

It had two arms (groups): Non-Hispanic Caucasians (experimental) and Participants of Japanese Descent (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 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.

Examples of who could join: Ability to voluntarily provide written, signed, and dated informed consent as applicable to participate in the study. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Subjects must be either:. A non-hispanic, Caucasian subject who has 2 non-hispanic, Caucasian parents and 4 non-hispanic, Caucasian grandparents. Male or nonpregnant, nonlactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of nonchildbearing potential.

The full record lists 13 inclusion and 22 exclusion criteria; among the exclusions: known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients; known history of alcohol or other substance abuse within the last year; use of the following prior to administration of investigational product within:.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

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 2017-05-16 with completion listed for 2017-06-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Baseline-adjusted Cmax of PTH(1-84). Baseline-adjusted Tmax of PTH(1-84). Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma.

It also tracked 11 secondary outcomes, for example Original Cmax of PTH(1-84) in Plasma, Original Tmax of PTH(1-84), Original AUClast of PTH(1-84) in Plasma, AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84), TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels and Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Parathyroid Hormone (PTH 1-84) in 24 people.

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

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.