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ST-2427Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D010149 Pain, Postoperative NIH 0.71

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 IV Infusion in Healthy Subjects

This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. The study will be conducted in 2 parts. In Part A of this study, subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. In Part B of this study, subjects will be randomized to receive up to 6 repeat doses of ST-2427 or placebo, administered twice-daily (BID) every 12 hours, in a Multiple Ascending Dose (MAD) design. In Part A and Part B, study drug (ST-2427 or placebo) will be administered intravenously (IV) over 1 hour. A total of 48 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.

NCT04475198 Acute, Post-operative Pain Drug: ST-2427 Drug: Placebo
MeSH:Pain, Postoperative

Primary Outcomes

Description: For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.

Measure: Incidence and severity of treatment-emergent adverse events

Time: Day 1 through Day 8

Description: Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP], will be used to analyze for change from baseline.

Measure: Incidence and severity of adverse events assessed by blood pressure

Time: Day 1 through Day 8

Description: Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections, using concentration-QTc analysis, and on other ECG parameters (heart rate, PR and QRS interval and treatment emergent T and U-wave abnormalities).

Measure: Incidence and severity of adverse events assessed by ECG

Time: Day 1 through Day 8

Description: The Holter recordings will also be analyzed for the presence of arrhythmias and for derivation of heart rate variability (HRV).

Measure: Incidence and severity of adverse events assessed by Continous Holter Monitoring

Time: Day 1 through Day 8

Description: Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.

Measure: Incidence and severity of treatment-emergent events assessed by clinical laboratory assessments

Time: Day 1 through Day 8

Description: Body weight (kg) will be assessed for changes relative to baseline.

Measure: Incidence and severity of adverse events assessed by body weight

Time: Day 1 through Day 8

Secondary Outcomes

Description: PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.

Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Cmax

Time: Day 1 through Day 5

Description: PK modeling will be performed using compartmental methods. The elimination half-life of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.

Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Elimination half-life

Time: Day 1 through Day 5

Description: PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.

Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Area under the curve

Time: Day 1 through Day 5

Description: The ST-2427 concentrations in the urine will be measured in 4 hour increments by cohort for the SAD.

Measure: Pharmacokinetics of ST-2427 concentration in urine

Time: Day 1 through Day 5

No related HPO nodes (Using clinical trials)