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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Gram-Positive Infections

Treatments: Drug: IV Tedizolid Phosphate; Drug: Oral Suspension Tedizolid Phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03217565

2017-000953-38 (EudraCT Number)

MK-1986-014 (Other Identifier)

1986-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 1 day to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 9 patient groups

Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: IV Tedizolid Phosphate

Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months

Experimental group

Description:

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.

Treatment:

Drug: Oral Suspension Tedizolid Phosphate

Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: Oral Suspension Tedizolid Phosphate

Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days

Experimental group

Description:

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.

Treatment:

Drug: Oral Suspension Tedizolid Phosphate