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

NCT05217537 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PTK0796-PEDPK-20110
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 (7)

• 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 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

Study Arms (2)

Cohort 1 (adolescents)

EXPERIMENTAL

12 to \< 18 years of age

Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet

Cohort 2 (children)

EXPERIMENTAL

8 to \< 12 years of age

Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet

Interventions

Omadacycline Injection [Nuzyra] DRUG

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

Also known as: NUZYRA

Cohort 1 (adolescents); Cohort 2 (children)

Omadacycline Oral Tablet DRUG

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

Also known as: NUZYRA

Cohort 1 (adolescents); Cohort 2 (children)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead

Study Sites (9)

Site 109

Little Rock, Arkansas, 72202, United States

Location

Site 112

Long Beach, California, 90806, United States

Location

Site 107

Orange, California, 92868, United States

Location

Site 114

Aurora, Colorado, 80045, United States

Location

Site 105

Chicago, Illinois, 60611, United States

Location

Site 111

Greenville, North Carolina, 27858, United States

Location

Site 106

Cleveland, Ohio, 60611, United States

Location

Site 113

Philadelphia, Pennsylvania, 19104, United States

Location

Site 108

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

omadacycline

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Paratek Medical Information
• Organization: Paratek Pharmaceuticals Inc

medinfo@paratekpharma.com

1-833-727-2835

Study Officials

• Amy Manley

  Paratek Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 1, 2022
• Study Start: April 6, 2022
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)