Pharmacokinetics and Safety Evaluation of Single-Dose Saroglitazar Magnesium in Subjects with Hepatic Impairment.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a phase 1 clinical trial.

Saroglitazar magnesium, a dual peroxisome proliferator-activated receptor agonist, is under evaluation for treating various liver conditions.

Treatment-emergent adverse events for safety were also evaluated.

Who Took Part

The abstract describes 23 subjects taking part.

Thirty-two subjects were enrolled in the hepatic-impaired groups and 23 subjects in the normal hepatic function group.

How the Study Was Run

The researchers set it up as an open-label and parallel-group study.

Nothing was hidden in this open-label Vitamin D, K2, Magnesium and Zinc study: the subjects and staff both knew the treatment.

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

What Was Measured

Saroglitazar magnesium, a dual peroxisome proliferator-activated receptor agonist, is under evaluation for treating various liver conditions.

Treatment-emergent adverse events for safety were also evaluated.

Topics PubMed links to this paper include Area Under Curve, Liver Diseases, Phenylpropionates and Pyrroles.

The authors tagged it with the keywords hepatic impairment, peroxisome proliferator-activated receptor (PPAR) agonist, portal hypertension and saroglitazar.

What This Means in Plain Language

The paper is an open-label and parallel-group study of Vitamin D, K2, Magnesium and Zinc in 23 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2023 (Clinical pharmacology in drug development), a journal based in United States.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.