A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

January 23, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old

The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Per protocol, PK analysis in Part A Group 1 will be conducted across ages in Cohorts 1 and 2 combined: Part A Group 1 Cohort 1 + Cohort 2: 28 days to <24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8127
        • UMHAT Deva Maria ( Site 2208)
      • Gabrovo, Bulgaria, 5300
        • MHAT Dr. Tota Venkova-Pediatrics ( Site 2218)
      • Montana, Bulgaria, 3400
        • MHAT "Dr. Stamen Iliev" Montana ( Site 2215)
      • Montana, Bulgaria, 3400
        • MHAT City Clinic Sv. Georgi EOOD ( Site 2202)
      • Pleven, Bulgaria, 5800
        • UMHAT Dr. Georgi Stranski EAD ( Site 2211)
      • Ruse, Bulgaria, 7002
        • MHAT Rousse-Neonatology ( Site 2213)
      • Ruse, Bulgaria, 7002
        • Multiprofile Hospital for Active Treatment - Ruse ( Site 2204)
      • Ruse, Bulgaria, 7002
        • UMHAT Kanev AD ( Site 2209)
      • Sliven, Bulgaria, 8800
        • MHAT Dr. Ival Seliminski ( Site 2212)
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Medical Center - 1- Sevlievo EOOD ( Site 2207)
    • Vratsa
      • Kozloduy, Vratsa, Bulgaria, 3320
        • MHAT Sv. Ivan Rilski EOOD ( Site 2201)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050010
        • Hospital San Vicente Fundacion ( Site 1103)
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 1106)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111221
        • Fundacion Hospital Infantil Universitario de San Jose ( Site 1107)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundacion Valle del Lili ( Site 1102)
  • Norway
    • Akershus
      • Loerenskog, Akershus, Norway, 1478
        • Akershus Universitetssykehus HF ( Site 1604)
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland Universitetssjukehus ( Site 1602)
    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • Stavanger Universitetssykehus, Helse Stavanger ( Site 1601)
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7006
        • St. Olavs Hospital. ( Site 1600)
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust ( Site 1700)
    • Lancashire
      • Liverpool, Lancashire, United Kingdom, L12 2AP
        • Alder Hey Childrens NHS Foundation Trust Hospital ( Site 1703)
    • Newcastle Upon Tyne
      • Newcastle, Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary ( Site 1702)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust ( Site 1704)
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital ( Site 1012)
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County ( Site 1001)
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital ( Site 1021)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1022)
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center. ( Site 1004)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis Children's Hospital ( Site 1020)
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital ( Site 1000)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity.
  • Is at least 1 kg in weight.
  • Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
  • Has no clinically significant ECG abnormalities.
  • Has sufficient vascular access to receive trial drug, and allow for required blood draws.
  • Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable.

Exclusion Criteria:

  • Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator.
  • Has used rifampin within 14 days prior to dosing.
  • Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing..
  • Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease.
  • Has a history of drug allergy or hypersensitivity to oxazolidinones.
  • Has had significant blood loss.
  • Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug.
  • Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study.
  • Has received another investigational product within the 30 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months
Pediatric participants 28 days to <6 months of age will receive a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months
Pediatric participants 6 months to <24 months of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days
Full term (FT) neonates from birth to <28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days
FT neonates from birth to <28 days of age will receive multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days
Preterm (PT) neonates from birth to <28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days
PT neonates from birth to <28 days of age will receive MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg, administered twice daily for 3 days.
Drug: IV Tedizolid Phosphate
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
Experimental: Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months
Pediatric participants 28 days to <24 months of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: Oral Suspension Tedizolid Phosphate
A single dose of tedizolid phosphate administered as an oral suspension.
Experimental: Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days
FT neonates from birth to <28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: Oral Suspension Tedizolid Phosphate
A single dose of tedizolid phosphate administered as an oral suspension.
Experimental: Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days
PT neonates from birth to <28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight <10 kg or 2.5 mg/kg for body weight 10 to <30 kg.
Drug: Oral Suspension Tedizolid Phosphate
A single dose of tedizolid phosphate administered as an oral suspension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Drug Concentration (AUC0-last) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of pharmacokinetic (PK) outcomes in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate t½ for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-last for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-inf for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Cmax for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Tmax for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate t½ for single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last]
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-last for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Cmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Tmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate
Time Frame: 1, 1.5, 3, 6, 12 and 24 hours post start of dosing
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to <24 months, across ages in Cohorts 1 and 2). As specified in the protocol, t½ for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
1, 1.5, 3, 6, 12 and 24 hours post start of dosing
Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last]
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single concentration listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, AUC0-inf of tedizolid metabolite could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in single dose (Part A Group 1[Cohorts 1 and 2],Group 2 Cohort 1, Group 3 Cohort 1; Part B[Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate
Time Frame: Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, t½ could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, t½ for tedizolid metabolite in single dose (Part A Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 3 Cohort 1; Part B [Groups 4, 5, 6]) were not included in this endpoint and have been reported separately in the record.
Day 3: pre-dose, 1, 1.5, 3, 6 and 12 hours post start of dosing
Part B: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension [AUC0-last]
Time Frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-last for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
1, 3, 5, 8, 12, and 24 hours post start of dosing
Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension
Time Frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-inf for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
1, 3, 5, 8, 12, and 24 hours post start of dosing
Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension
Time Frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
1, 3, 5, 8, 12, and 24 hours post start of dosing
Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension
Time Frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
1, 3, 5, 8, 12, and 24 hours post start of dosing
Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension
Time Frame: 1, 3, 5, 8, 12, and 24 hours post start of dosing
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, t½ for tedizolid metabolite in Part A (Group 1 [Cohorts 1 and 2], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
1, 3, 5, 8, 12, and 24 hours post start of dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With an Adverse Event (AE)
Time Frame: Up to approximately 21 days
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE was reported for each arm.
Up to approximately 21 days
Number of Participants That Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 3 days
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported for each arm.
Up to approximately 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1986-014
  • MK-1986-014 (Other Identifier: MSD Protocol Number)
  • 2017-000953-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gram-Positive Infections

Clinical Trials on IV Tedizolid Phosphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings