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ST-2427 for Postoperative Pain

Phase 1

Waitlist Available

Research Sponsored by SiteOne Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-48 hours

Awards & highlights

Study Summary

This trial will test a new drug to see if it is safe and what effects it has on the body. 30 people will be given the drug or a placebo, and the study will observe how they react.

Eligible Conditions

Postoperative Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Adverse Events Assessed by Blood Pressure

Number of Participants With Adverse Events Assessed by Body Weight

Number of Participants With Adverse Events Assessed by ECG

+2 more

Secondary outcome measures

Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve

Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax

Trial Design

5Treatment groups

Experimental Treatment

Group I: Single Ascending Dose: Cohort 5Experimental Treatment2 Interventions

33 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.

Group II: Single Ascending Dose: Cohort 4Experimental Treatment2 Interventions

22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.

Group III: Single Ascending Dose: Cohort 3Experimental Treatment2 Interventions

15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.

Group IV: Single Ascending Dose: Cohort 2Experimental Treatment2 Interventions

10 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.

Group V: Single Ascending Dose: Cohort 1Experimental Treatment2 Interventions

5 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (ST-2427 n=1, placebo n=1) before remainder of cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SiteOne Therapeutics, Inc.Lead Sponsor

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,325 Total Patients Enrolled

1 Trials studying Postoperative Pain

113 Patients Enrolled for Postoperative Pain

Markus Jerling, MD, PhDStudy DirectorUnaffliated

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is ST-2427 an officially recognized pharmaceutical by the Food and Drug Administration?

"Due to the preliminary nature of this medical trial, ST-2427 was given a score of 1 when assessing its safety. This is in part due to limited data regarding both efficacy and safeguards."

Answered by AI

Is the recruitment process for this research study open to persons of advanced age?

"According to the trial's stipulations, only those between 18 and 55 years old are eligible for enrollment."

Answered by AI

What is the purpose of this research investigation?

"This research study, set between Days 1 and 8, has the primary goal of assessing any adverse effects caused by changes in blood pressure. Secondary outcomes measure the pharmacokinetics of ST-2427 concentration in urine (SAD), whole blood AUCs after infusion, as well as maximum concentrations observed post-infusion."

Answered by AI

Is enrollment for this clinical trial ongoing at this time?

"According to clinicaltrials.gov, this medical trial is no longer actively seeking out candidates - it was first posted on March 4th 2021 and last updated on May 6th 2022. However, there are currently 483 other studies looking for volunteers at the moment."

Answered by AI

Is there an opportunity to become involved in this research endeavor?

"This clinical trial has space for 30 participants suffering from postoperative pain, who must meet several requirements to be considered. Eligible candidates should be adults between the ages of 18 and 55 that are in generally good health; further criteria include having a body mass index (BMI) within 18.0-35.0 kg/m2, hemoglobin/hematocrit results within normal range, non-smokers with no use of any tobacco product or marijuana for at least one month prior to enrollment, possessing written informed consent and suitable venous access for blood sampling approved by an investigator during screening."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427

2021. "Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04475198.