Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents (NCT04700787) | Clinical Trial Compass
WithdrawnPhase 1
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
Stopped: Enrollment challenges and change in development plan necessitating a change in study design
United States0Started 2021-04-30
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.
Who can participate
Age range12 Years ā 18 Years
SexALL
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Inclusion criteria
ā. Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board \[IRB\] according to local regulations and guidelines) must be obtained prior to any study-related procedures.
ā. Patient is male or female adolescent who are ā„12 and \<18 years of age.
ā. Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician
ā. Patient will be hospitalized for urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection for at least 48 hours and be receiving appropriate anti-infective treatment.
ā. Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables.
ā. Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening.
ā. Post-menarchal females and post-pubertal males must agree to use a highly effective method of birth control with partners of childbearing potential throughout the duration of the study and for 1 month following the last dose of study drug.
ā. Patient must be willing to follow all study procedures.
Exclusion criteria
ā. Patient has creatinine clearance \<90 mL/min using the Cockcroft-Gault formula.
ā. Patient is unable to tolerate oral medications.
What they're measuring
1
Maximum plasma concentration
Timeframe: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose