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

Paratek Pharmaceuticals Inc23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bacterial Infections

Interventions

Omadacycline Injection [Nuzyra]DRUG

Single dose of 100 mg omadacycline IV in 100 mL of normal saline

Omadacycline Oral TabletDRUG

Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (9)

Site 109

Little Rock, Arkansas, United States

Site 112

Long Beach, California, United States

Site 107

Orange, California, United States

Site 114

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

AUC(0-48) of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Pre-dose (At least 15 minutes prior to IV infusion), and 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

AUClast of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

Data from ClinicalTrials.gov

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Site 105

Chicago, Illinois, United States

Site 111

Greenville, North Carolina, United States

Site 106

Cleveland, Ohio, United States

Site 113

Philadelphia, Pennsylvania, United States

Site 108

Houston, Texas, United States

AUC0-inf of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

Cmax of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

Tmax of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine t1/2 and was calculated by using formula. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

t1/2 of Omadacycline After Oral Administration

Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing

Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

Systemic Clearance (CL) of Omadacycline After IV Infusion

Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.

Time frame: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion

Secondary Outcomes

Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.

An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure.

Time frame: Up to Day 7

Number of Participants Reporting TEAE by Severity

Time frame: Up to Day 7

Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was any event that had not been present before exposure to the study drug, or any event that had already been present but worsened in intensity or frequency after exposure. An SAE was any adverse event that resulted in death, required hospitalization, persistent or significant disability, congenital anomaly.

Time frame: Up to Day 7

Number of Participants With Change From Baseline in Hematology Parameters

Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, hematocrit, leukocytes, platelets, mean cell volume, platelet count, white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, monocytes and basophils.

Time frame: Up to Day 2

Number of Participants With Change From Baseline in Serum Chemistry Parameters

Blood samples were collected for the assessment of blood glucose, urea, creatinine, sodium, potassium, chloride, bicarbonate, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), total bilirubin, total protein, albumin, creatine phosphokinase (CK), calcium, phosphate, cholesterol, urate, amylase, lipase and gamma-glutamyl transpeptidase (GGT).

Time frame: Up to Day 2

Number of Participants With Change From Baseline in Vital Signs

Vital signs included blood pressure, heart rate, and oral body temperature and were collected at the specified timepoints. Vital signs were measured after participants had remained in a supine position for at least 5 minutes using an automated calibrated device.

Time frame: Up to Day 2

Number of Participants With Clinically Significant Changes in Physical Examination

A comprehensive physical examination was conducted, encompassing general appearance, skin, neck, eyes, ears, nose, throat, lungs, heart, abdomen, lymph nodes, extremities, and brief neurological exam.

Time frame: Up to Day 2