NCT00874757

Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects

Completed Results posted Last updated 23 August 2024

What this trial tests

trial testing Rosuvastatin in Healthy in 20 participants. Completed in 1 September 2011.

Timeline

15 November 2010

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	University of Nebraska
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	15 November 2010
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	1 location across United States

Drugs / interventions tested

• Rosuvastatin (rosuvastatin) — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of Nebraska

Who can join

Adults 19 to 39, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Toll-like Receptor 4 Expression Pre- and Post-Treatment Primary · Before and after three weeks of treatment with rosuvastatin

Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.

Group	Value	95% CI
Pre-treatment Tlr-4 Expression	12.37	± 9.8
Post-treatment Trl-4 Monocyte Expression	6.36	± 4.8

Tumor Necrosis Factor (TNF) Secondary · Pre and post 3 weeks of rosuvastatin treatment

Inflammatory cytokine generated after treatment of whole blood collected before and after rosuvastatin treatment

Group	Value	95% CI
Baseline (Pre-Rosuvastatin Treatment)	145	± 52
Post Rosuvastatin Treatment	92	± 25

Interleukin-6 Secondary · Before (baseline) and after 3 weeks of rosuvastatin treatment

Interleukin-6 inflammatory cytokine which will be released after LPS treatment of blood

Group	Value	95% CI
Interleukin-6 Baseline (Before Rosuvastatin Treatment)	4.8	± 1.3
Interleukin-6 Post-treatment	4.1	± 1.0

Interleukin-8 Secondary · measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment

Interleukin-8 an inflammatory cytokine which will be releases after LPS treatment.

Group	Value	95% CI
Pre-Treatment IL-8	155	± 45
Post-treatment IL-8	125	± 27

Adverse events — posted to ClinicalTrials.gov

Time frame: Collected over 3 weeks for each subject. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rosuvastatin

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (2 terms — click to expand)

Reaction	System	Rosuvastatin
Muscle pain	Musculoskeletal and connective tissue disorders	—
insomnia	General disorders	—

Data from ClinicalTrials.gov NCT00874757 adverse events section.

Sponsor's own description

The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.
   Khan S, Huda B, Bhurka F, Patnaik R, et al · · 2025 · cited 7× · PMID 40943351 · DOI 10.3390/ijms26178429