Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

What Was Tested

In this phase 1 trial, researchers set out to test Romiplostim.

It had two arms (groups): TR Sequence (experimental) and RT Sequence (experimental).

First Intervention period - subjects are administered test medecine (GP40141) and in seconde Intervention period subjects are administered reference medecine (Nplate).

First Intervention period subjects are administered reference medecine (Nplate) and in seconde Intervention period subjects are administered test medecine (GP40141).

The registry classes the interventions as drug.

More on the Plan

Conduct a comparative analysis of data on adverse events (AE) and evaluate immunogenicity after a single subcutaneous administration of GP40141 versus Enplate®.

The safety of the compared drugs will be assessed by emergence and development of AE.

Who Took Part

56 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

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

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Romiplostim, so expectations could not easily colour the readings.

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

It started in 2022-06-03 with completion listed for 2024-06-30.

It ran at 1 site in Russia.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: AUCplt (time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection). Pmax (time frame: -45, -30, -15 min and days 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32 post injection).

It also tracked 7 secondary outcomes, for example Pmax/P0, tPmax, AUC0-t, Cmax, Tmax and T1/2.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Romiplostim in 56 people.

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

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