A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections - A Single-dose Pharmacokinetics Study of MK-7655A in Pediatric Subjects

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites47 target enrollmentMay 29, 2017

ConditionsTreatment of bacterial infections in pediatric populations MedDRA version: 20.0Level: LLTClassification code 10071097Term: Beta-lactam antibiotic resistanceSystem Organ Class: 100000004862 Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsRecarbrio

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment of bacterial infections in pediatric populations
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 47
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 29, 2017

End Date

August 11, 2020

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Have a parent or LAR who provides written informed consent for the trial on the subject’s behalf after understanding the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to allow the subject to participate. Assent is to be obtained from minors as applicable according to institutional practices.
•2\.Be able to comply with the protocol for the duration of the study
•3\.Be male or female from birth to \<18 years of age at screening
•4\. For Cohorts 4 and 5, is at least 37 weeks postmenstrual age at the time of screening. Postmenstrual age is calculated by adding the gestational age at the time of birth to the chronological age at the time of screening.
•5\.Be hospitalized, currently receiving antibacterial treatment for confirmed or suspected Gram\-negative bacterial infection, and expected to require hospitalization until at least 24 hours after completion of study drug administration. Subjects who are not receiving antibacterial treatment for the qualifying infection at the time of screening are eligible for this trial if either (1\) they will be initiating antibacterial treatment for the qualifying infection prior to study drug administration, or (2\) they have recently (within 48 hours prior to study drug administration) completed antibacterial treatment for the qualifying infection
•6\.Meet 1 of the following categories: a)The subject is a male who is not of reproductive potential, defined as a male who has azoospermia; b)The subject is a female who is not of reproductive potential, defined as a female who either: (1\) who has not undergone menarche, (2\) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening, OR (3\) has a congenital or acquired condition that prevents childbearing.; c) The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner from the time of consent through 24 hours after completion of study drug administration by complying with 1 of the following: (1\) practice abstinence from heterosexual activity OR (2\) use (or have their partner use) acceptable contraception during heterosexual activity.Acceptable
•methods of contraception are:Single method (1 of the following is acceptable):a)intrauterine device,b)vasectomy of a female subject’s male partner C)contraceptive rod implanted into the skin. Combination method (requires use of 2 of the following):a)diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide) b)cervical cap with spermicide (nulliparous women only) c)contraceptive sponge (nulliparous women only) d)male condom or female condom (cannot be used together) e)hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin\-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethical Review Committee (ERCs)/Institutional Review Boards (IRBs). Periodic abstinence (e.g., calendar, ovulation, sympto\-thermal, post\-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
•7\. Have clinically stable renal function at the time of screening that is

Exclusion Criteria

•1\.Has a personal history of hypersensitivity to IMI or to any of the following: a) Any carbapenem, cephalosporin, penicillin, or other ß\-lactam agent b) Other BLIs (e.g., tazobactam, sulbactam, clavulanic acid, avibactam)
•2\.If female, is currently pregnant or breast feeding or has a positive serum ß\-human chorionic gonadotropin (ß\-hCG) pregnancy test prior to administration of the study drug.
•3\.Has a history of a seizure disorder (requiring ongoing treatment with anti\-convulsive therapy or prior treatment with anti\-convulsive therapy within the last 3 years)
•4\.Has used or plans to use valproic acid or divalproex sodium within 2 weeks prior to screening or at any point between screening and 24 hours after the completion of study drug infusion
•5\.Has received treatment or plans to receive treatment with any carbapenem antibiotic within 48 hours prior to initiation of study drug infusion or at any point between administration of study drug and the last PK sample collection
•6\.Has used or plans to use any of the following medications, which are organic anion transporter (OAT) 1 or OAT3 inhibitors, within 1 week prior to screening or at any point between screening and the last PK sample collection: cimetidine, probenecid, indomethacin, mefenamic acid, furosemide or other loop diuretics, (eg, bumetanide, torsemide, ethacrynic acid), angiotensin receptor blockers, (eg, valsartan), and
•7\.Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to screening
•8\.Has enrolled previously in the current trial and been discontinued, or has received REL for any other reason
•9\.Has a current diagnosis of cystic fibrosis, meningitis, or severe sepsis
•10\.Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial