Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers

What Was Tested

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

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

Icatibant has been approved in over 40 countries around the world including the United States (US) and Europe for the treatment of acute attacks of hereditary angioedema (HAE) in adults.

This is an open-label, single-arm study that will enroll at least 12 Japanese subjects (in order to have 12 subjects complete the study), age 18-55 years inclusive.

The study will be conducted at 1 site in the US.

The study will consist of a Screening Period, a Treatment Period, and a Follow-Up Period.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Japanese; defined as born in Japan, lived outside of Japan for no more than 10 years, and having Japanese parents and Japanese maternal and paternal grandparents. Body mass index of 18 to 28 kg/m2, inclusive.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: history of drug allergy or other allergy that, in the opinion of the investigator, contraindicates participation; pregnant or lactating females.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Icatibant study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-02-21 with completion listed for 2014-02-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Peak Plasma Concentration (Cmax) of Icatibant and Metabolites. Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites. Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites.

It also tracked 6 secondary outcomes, for example The Total Number of Treatment-Emergent Adverse Events, The Percentage of Subjects With Any Injection Site Reactions, Change From Baseline in Diastolic Blood Pressure, Change From Baseline in Systolic Blood Pressure and Change From Baseline in Pulse Rate.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Icatibant in 12 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 Icatibant compound page, all human trials.