Phase 1 Completed N=47 Treatment

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

Gram-Positive Infections

Source: ClinicalTrials.gov NCT03217565 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Jul 2024

Primary outcomePrimary: 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 — NA; NA; NA hr*μg/mL

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	NA; NA; NA	—
PRIMARY Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA; NA; NA	—
PRIMARY Part A: Maximum Concentration (Cmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA; NA; NA	—
PRIMARY Part A: Time to Reach Maximum Concentration (Tmax) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA; NA; NA	—
PRIMARY Part A: Apparent Terminal Half-life (t½) of Tedizolid Phosphate (Prodrug) After Single-dose IV Administration	NA; NA; NA	—
PRIMARY Part A: AUC0-last of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	NA	—
PRIMARY Part A: AUC0-inf of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	NA	—
PRIMARY Part A: Cmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	NA	—
PRIMARY Part A: Tmax of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	NA	—
PRIMARY Part A: t½ of Tedizolid Phosphate (Prodrug) After Multiple-dose IV Administration	NA	—
PRIMARY Part A: AUC0-24 of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate [AUC0-last]	13.6; 8.23; 15.6	—
PRIMARY Part A: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	14.3; 9.21; 17.8	—
PRIMARY Part A: Cmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	2.19; 0.962; 1.35	—
PRIMARY Part A: Tmax of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	1.33; 1.41; 1.50	—
PRIMARY Part A: t½ of Tedizolid (Active Metabolite) After Single-dose IV Administration of Tedizolid Phosphate	4.17; 6.63; 7.08	—
PRIMARY Part A: AUC0-12 of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate [AUC0-last]	10.5; 7.48	—
PRIMARY Part A: Cmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	1.82; 1.69	—
PRIMARY Part A: Tmax of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	1.60; 1.08	—
PRIMARY Part A: AUC0-inf of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	—	—
PRIMARY Part A: t½ of Tedizolid (Active Metabolite) After Multiple-dose IV Administration of Tedizolid Phosphate	—	—
PRIMARY 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]	7.92; 9.25; 14.9	—
PRIMARY Part B: AUC0-inf of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	8.36; 9.44; 22.1	—
PRIMARY Part B: Cmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	1.32; 0.899; 1.22	—
PRIMARY Part B: Tmax of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	1; 3.03; 8	—
PRIMARY Part B: t½ of Tedizolid (Active Metabolite) After Single-dose Administration of Tedizolid Phosphate Oral Suspension	5.73; 3.82; 13.4	—
SECONDARY Number of Participants With an Adverse Event (AE)	1; 1; 0; 0; 2; 2	—
SECONDARY Number of Participants That Discontinued Study Treatment Due to an AE	0; 0; 0; 0; 0; 0	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT03217565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.