A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)

NCT ID: NCT02750761

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2018-12-21

Brief Summary

This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B) administration to hospitalized participants ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4, respectively).

Detailed Description

Part A (IV):

• Group 1 (Cohort 1 and Cohort 2) (6 to <12 years)
• Group 2 (Cohort 1 and Cohort 2) (2 to <6 years)

Part B (Oral Suspension):

• Group 3 (6 to <12 years)
• Group 4 (2 to <6 years)

In Cohort 1 of Group 1 (IV) participants received a single administration of tedizolid phosphate at 5 mg/kg of total body weight. After all participants in Cohort 1 of Group 1 received study drug, a preliminary analysis of the safety and PK data was performed and results were used to select 4 mg/kg as the appropriate dose for Cohort 2 of Group 1 and Group 3, and to select 6 mg/kg as the starting dose for the younger participants, Cohort 1 of Group 2. After all participants in Cohort 1 of Group 2 receive study drug, another preliminary analysis of the safety and PK data will be performed and results will be used to confirm 6 mg/kg as the appropriate dose for Cohort 2 of Group 2. Similarly, the Group 4 dose will be confirmed after data review of Group 3 results.

Conditions

Gram-Positive Bacterial Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years)

Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (IV)

Intervention Type: DRUG

200 mg/vial powder for injection

Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years)

Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (IV)

Intervention Type: DRUG

200 mg/vial powder for injection

Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years)

Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (IV)

Intervention Type: DRUG

200 mg/vial powder for injection

Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years)

Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (IV)

Intervention Type: DRUG

200 mg/vial powder for injection

Group 3: Tedizolid oral 4 mg/kg (6 to <12 years)

Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (oral suspension)

Intervention Type: DRUG

Powder for oral suspension 20 mg/mL following reconstitution

Group 4: Tedizolid oral 3 mg/kg (2 to <6 years)

Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate.

Group Type: EXPERIMENTAL

Tedizolid Phosphate (oral suspension)

Intervention Type: DRUG

Powder for oral suspension 20 mg/mL following reconstitution

Interventions

Tedizolid Phosphate (IV)

200 mg/vial powder for injection

Intervention Type: DRUG

Tedizolid Phosphate (oral suspension)

Powder for oral suspension 20 mg/mL following reconstitution

Intervention Type: DRUG

Other Intervention Names

Sivextro; TR-701 FA; MK-1986; Sivextro; TR-701 FA; MK-1986

Eligibility Criteria

Inclusion Criteria

• Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
• Weight >5th percentile and <95th percentile based on age;
• Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
• Females must be premenarchal, abstinent, or practicing an effective method of birth control;

Exclusion Criteria

• History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
• Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
• History of drug allergy or hypersensitivity to oxazolidinones;
• Pregnant or breast feeding;
• Significant blood loss within 60 days prior to study start;
• Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
• Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
• Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
• Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

Colombia; Norway; Ukraine; United Kingdom; United States

References

Arrieta AC, Ang JY, Espinosa C, Fofanov O, Tondel C, Chou MZ, De Anda CS, Kim JY, Li D, Sabato P, Sears PS, Bradley JS. Pharmacokinetics and Safety of Single-dose Tedizolid Phosphate in Children 2 to <12 Years of Age. Pediatr Infect Dis J. 2021 Apr 1;40(4):317-323. doi: 10.1097/INF.0000000000003030.

Reference Type: DERIVED

PMID: 33710976 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TR701-120

Identifier Type: OTHER

Identifier Source: secondary_id

2015-004595-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-1986-013

Identifier Type: OTHER

Identifier Source: secondary_id

1986-013

Identifier Type: -

Identifier Source: org_study_id