Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

NCT04700787 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IT001-106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Tract Infections; Pyelonephritis Acute; Intraabdominal Infections

Outcome Measures

Primary Outcomes (1)

• Maximum plasma concentration

  Maximum plasma concentration (Cmax) of sulopenem at multiple timepoints after dose

  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

Secondary Outcomes (10)

• Time to maximum plasma concentration

  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

• Time above minimum inhibitory concentration

  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

• Area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration

  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

• Area under the plasma concentration-time curve from time zero extrapolated to infinity

  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

• Percentage of area under the concentration-time curve extrapolated

  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

Study Arms (1)

Sulopenem

EXPERIMENTAL

Sulopenem intravenous 1000 mg (single dose) on Day 1 followed by oral sulopenem etzadroxil/probenecid 500 mg/500 mg (single dose) on Day 2.

Drug: Sulopenem

Interventions

Sulopenem DRUG

sulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2

Sulopenem

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Patient is male or female adolescent who are ≥12 and \<18 years of age.
• Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician
• 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.
• Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables.
• Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening.
• 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.
• Patient must be willing to follow all study procedures.

You may not qualify if:

• Patient has creatinine clearance \<90 mL/min using the Cockcroft-Gault formula.
• Patient is unable to tolerate oral medications.
• Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene
• Patient has signs of severe sepsis
• Patient has evidence of active liver disease or hepatic dysfunction
• Patient has neutropenia with absolute neutrophil count \<500 cells/mm3.
• Patient has history of solid organ transplantation reported at any time.
• Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.
• Patient has known allergies to penicillin, carbapenems, and/or cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past.
• Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools.
• Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
• Patient has involvement in the planning and/or conduct of this study
• Patient has participated in any other clinical study where an investigational product was ingested within 30 days or 5 half-lives of the drug (whichever is longer) prior to the current study.
• Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions.
• Patient has history or presence of GI, hepatic, or renal disease, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead

Study Sites (1)

Medical Facility

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Intraabdominal Infections

Interventions

sulopenem

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Steven I Aronin, MD

  Employee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: April 30, 2021
• Primary Completion: March 25, 2022
• Study Completion: April 4, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)