CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 26 enrolled
Drug / intervention
Compound 21 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05576155
NCT05576155Early Ph 1Completed

Sex Differences in the Dilatory Response of Compound 21

Anna Stanhewicz, PhD·interventional·Posted Oct 12, 2022·Updated Dec 31, 2024

In Brief

A Early Phase 1 clinical trial evaluating Compound 21 and Compound 21 + losartan for Sex Differences. Completed, enrolled 26 participants across 1 site.

Detailed Summary

When blood pressure changes, Angiotensin II is produced and released into the bloodstream. This substance can make blood vessels smaller (i.e., vasoconstriction) by acting through Angiotensin II type I receptors (AT1R) to increase blood pressure. Or it can increase the diameter of vessels (i.e., vasodilation) through Angiotensin II type II receptors (AT2R) to decrease blood pressure. These two receptors normally work in balance to maintain blood pressure. However, excess Angiotensin II released in the bloodstream may reduce the sensitivity of AT2Rs, leading to excessive activation of AT1Rs. This results in increased constriction which plays a major role in diseases such as high blood pressure, hardening of the arteries, and heart failure. In the body, Angiotensin II production is reduced in the presence of estrogen, as seen in pre-menopausal women. Pre-menopausal women have a greater protection against cardiovascular diseases compared to age-matched males, likely due to the protective effects of estrogen. However, the extent that estrogen may impact the sensitivity of Angiotensin II receptors in pre-menopausal is unknown. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents), the blood vessels in a dime-sized area of the skin are studied in healthy young women and men. As a compliment to these measurements, blood is drawn from the subjects and circulating factors that may contribute to cardiovascular health are measured.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSex Differences
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2023202420252026
First PostedOct 12, 2022
Enrollment StartOct 3, 2022
Primary CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.7 years ago

Interventions

Compound 21drug

Compound 21 + Ringer's is perfused at 10 doses increasing serially for 10 minutes each from 10\^-12 M to 10\^-3 M

Compound 21 + losartandrug

Compound 21 + losartan (43 µM) is perfused at 10 doses increasing serially for 10 minutes each from 10\^-12 M to 10\^-3 M.