Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects

What Was Tested

This registered phase 1 trial tested Exenatide.

It had four arms (groups): Group 1: Normal (experimental), Group 2: Mild Renal Dysfunction (experimental), Goup 3: Moderate Renal Dysfunction (experimental) and Group 4: Moderate Renal Dysfunction (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 25 years up to 80 years.

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

Examples of who could join: Body mass index between 22 and 40 kg/m². Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: history of acute metabolic complications; uncontrolled hypertension; history of hypersensitivity to exenatide.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Exenatide study did not mask who received what.

It started in 2014-11 with completion listed for 2015-07.

It ran at 4 sites in Germany (3) and United States (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 24-h Area under the Curve at steady state (AUCt,ss) (time frame: Approximately 67 Days).

It also tracked 6 secondary outcomes, for example Rate of adverse events, Severity of adverse events, Safety laboratory parameters, Vital signs, Electrocardiogram and Physical exam.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Exenatide in 38 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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