Phase 1 N=23 Other

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

Bacterial Infections

Bottom Line

View on ClinicalTrials.gov: NCT05217537 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion — 8990; 13300 hours*nanograms per milliliter (h*ng/ml)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Omadacycline Injection [Nuzyra] (Drug); Omadacycline Oral Tablet (Drug)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: Paratek Pharmaceuticals Inc
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion	8990; 13300	—
PRIMARY AUC(0-48) of Omadacycline After Oral Administration	6860; 17900	—
PRIMARY AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion	9010; 13300	—
PRIMARY AUClast of Omadacycline After Oral Administration	6550; 9860	—
PRIMARY AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion	9720; 14100	—
PRIMARY AUC0-inf of Omadacycline After Oral Administration	7450; 18600	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion	1270; 1600	—
PRIMARY Cmax of Omadacycline After Oral Administration	528; 946	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion	0.66; 0.81	—
PRIMARY Tmax of Omadacycline After Oral Administration	2.98; 2.00	—
PRIMARY Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion	12.9; 11.9	—
PRIMARY t1/2 of Omadacycline After Oral Administration	12.7; 10.7	—
PRIMARY Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion	191; 122	—
PRIMARY Systemic Clearance (CL) of Omadacycline After IV Infusion	10.3; 7.10	—
SECONDARY Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.	0; 2; 1; 1; 3; 2	—
SECONDARY Number of Participants Reporting TEAE by Severity	2; 4; 4; 0; 1; 0	—
SECONDARY Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug	3; 4; 4; 3; 0; 0	—
SECONDARY Number of Participants With Change From Baseline in Hematology Parameters	2; 0; 0; 0; 3; 0	—
SECONDARY Number of Participants With Change From Baseline in Serum Chemistry Parameters	1; 0; 0; 0; 1; 0	—
SECONDARY Number of Participants With Change From Baseline in Vital Signs	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes in Physical Examination	0; 0; 0; 0	—

Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.

Eligibility Criteria

Inclusion Criteria

Male or female subjects, age 8 to < 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
Weight within the 5th and 95th percentile for age and sex.
Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study

Exclusion Criteria

Evidence of a medical condition that may pose a safety risk or impair study participation.
Confirmed or suspected SARS-CoV-2 infection.
Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
Has received an investigational drug within the past 30 days.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05217537). 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.