Safety, tolerability, and pharmacokinetics of SR 49059, a V1a vasopressin receptor antagonist, after repeated oral administration in healthy volunteers

What Was Tested

The paper reports a study of Vasopressin, published as a clinical trial, phase i.

The conventional evaluation of safety and tolerability during Phase I may not be sufficient for new exploratory non-peptide receptor antagonists as selective vasopressin (AVP) receptor antagonists.

Steady state SR 49059 levels were achieved on days 4-5 with moderate (1.8-2.4 fold) accumulation (t1/2: 32 hrs).

Who Took Part

The abstract describes 50 subjects taking part.

By PubMed's age tags, the people studied were adults, men only.

How the Study Was Run

The researchers set it up as a double-blind and placebo-controlled study.

Blinding on both sides kept the subjects and researchers unaware of who received Vasopressin.

A placebo (an inactive look-alike) gave the Vasopressin group a baseline to be compared against.

The methods mention a period of 7 days.

What Was Measured

The conventional evaluation of safety and tolerability during Phase I may not be sufficient for new exploratory non-peptide receptor antagonists as selective vasopressin (AVP) receptor antagonists.

Steady state SR 49059 levels were achieved on days 4-5 with moderate (1.8-2.4 fold) accumulation (t1/2: 32 hrs).

Topics PubMed links to this paper include Antidiuretic Hormone Receptor Antagonists, Arginine Vasopressin, Blood Platelets, Blood Pressure, Diuresis, Hormone Antagonists and Indoles.

What This Means in Plain Language

The paper is a double-blind and placebo-controlled study of Vasopressin in 50 subjects over 7 days.

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 1998 (Advances in experimental medicine and biology), a journal based in United States.

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