A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections
Overview
- Phase
- Phase 1
- Intervention
- Omadacycline Oral Tablet
- Conditions
- Bacterial Infections
- Sponsor
- Paratek Pharmaceuticals Inc
- Enrollment
- 23
- Locations
- 9
- Primary Endpoint
- Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion
- Status
- Completed
- Last Updated
- last month
Overview
Brief 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.
Investigators
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.
Arms & Interventions
Cohort 2 (children)
8 to \< 12 years of age
Intervention: Omadacycline Oral Tablet
Cohort 1 (adolescents)
12 to \< 18 years of age
Intervention: Omadacycline Injection [Nuzyra]
Cohort 1 (adolescents)
12 to \< 18 years of age
Intervention: Omadacycline Oral Tablet
Cohort 2 (children)
8 to \< 12 years of age
Intervention: Omadacycline Injection [Nuzyra]
Outcomes
Primary Outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC(0-48) of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUClast of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC0-inf of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Cmax of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Tmax of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion
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
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.
t1/2 of Omadacycline After Oral Administration
Time Frame: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Systemic Clearance (CL) of Omadacycline After IV Infusion
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
Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Secondary Outcomes
- Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.(Up to Day 7)
- Number of Participants Reporting TEAE by Severity(Up to Day 7)
- Number of Participants With Clinically Significant Changes in Physical Examination(Up to Day 2)
- Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug(Up to Day 7)
- Number of Participants With Change From Baseline in Hematology Parameters(Up to Day 2)
- Number of Participants With Change From Baseline in Serum Chemistry Parameters(Up to Day 2)
- Number of Participants With Change From Baseline in Vital Signs(Up to Day 2)