Bacterial InfectionsPhase 1NCT05217537

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

A Phase 1 study testing Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet in people with Bacterial Infections, run by Paratek Pharmaceuticals Inc at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Bacterial Infections
What is being tested?: Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 9 sitesUnited States
Study dates: 6 Apr 2022to 27 Feb 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Site 114
Aurora, Colorado, 80045
Site 105
Chicago, Illinois, 60611
Site 106
Cleveland, Ohio, 60611
Site 111
Greenville, North Carolina, 27858
Site 108
Houston, Texas, 77030
Site 109
Little Rock, Arkansas, 72202
Site 112
Long Beach, California, 90806
Site 107
Orange, California, 92868
Site 113
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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

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
Being tested: Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omadacycline Injection [Nuzyra]Drug
Also called NUZYRA
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
Omadacycline Oral TabletDrug
Also called NUZYRA
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)

Study groups in NCT05217537
Study group	Role	What they receive
Cohort 1 (adolescents)	Experimental	12 to < 18 years of age Receives: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet
Cohort 2 (children)	Experimental	8 to < 12 years of age Receives: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Up to Day 7
Number of Participants Reporting TEAE by Severity
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 202227 Feb 2025

First posted1 Feb 2022
Study start6 Apr 2022
Primary completion27 Feb 2025
Study completion27 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05217537
Sponsor's protocol ID: PTK0796-PEDPK-20110
Status last verified: Feb 2026
First submitted: 15 Dec 2021
Last updated: 9 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05217537
Acronym / sponsor ID: PTK0796-PEDPK-20110
Conditions: Bacterial Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: 6 Apr 2022 (actual)
Primary completion: 27 Feb 2025 (actual)
Study completion: 27 Feb 2025 (actual)
First posted: 1 Feb 2022 (actual)
Results: Posted 9 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1 (adolescents)	Experimental	Drug: Omadacycline Injection [Nuzyra], Drug: Omadacycline Oral Tablet12 to < 18 years of age
Cohort 2 (children)	Experimental	Drug: Omadacycline Injection [Nuzyra], Drug: Omadacycline Oral Tablet8 to < 12 years of age

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omadacycline Injection [Nuzyra]Also: NUZYRASingle dose of 100 mg omadacycline IV in 100 mL of normal saline	Drug	Cohort 1 (adolescents), Cohort 2 (children)
Omadacycline Oral TabletAlso: NUZYRASingle dose of 300 mg omadacycline PO (2 x 150 mg tablets)	Drug	Cohort 1 (adolescents), Cohort 2 (children)

Primary outcome

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.

7 secondary outcomes

Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.
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
Time frame: Up to Day 7
Number of Participants With Change From Baseline in Hematology Parameters
Time frame: Up to Day 2
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Time frame: Up to Day 2
Number of Participants With Change From Baseline in Vital Signs
Time frame: Up to Day 2
Number of Participants With Clinically Significant Changes in Physical Examination
Time frame: Up to Day 2

Results and safety

Results posted to the registry on 9 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescents, Cohort 1: 100 mg IV Omadacycline	6	6
Adolescents, Cohort 1: 300 mg Oral Omadacycline	7	7
Children, Cohort 2: 100 mg IV Omadacycline	6	6
Children, Cohort 2: 300 mg Oral Omadacycline	4	4

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanograms per milliliter (h*ng/ml)

Measure	Adolescents, Cohort 1: 100 mg IV Omadacycline n = 6	Children, Cohort 2: 100 mg IV Omadacycline n = 6
Value	8990 (27.3)	13300 (40.1)

Population analysed: Pharmacokinetic Evaluable Population include all participants who received study drug and have at least one evaluable pharmacokinetic parameter.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/ml

Measure	Adolescents, Cohort 1: 300 mg Oral Omadacycline n = 7	Children, Cohort 2: 300 mg Oral Omadacycline n = 1
Value	6860 (81.5)	17900 (NA)

Population analysed: Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/ml

Measure	Adolescents, Cohort 1: 100 mg IV Omadacycline n = 6	Children, Cohort 2: 100 mg IV Omadacycline n = 6
Value	9010 (27.4)	13300 (40.2)

Population analysed: Pharmacokinetic Evaluable Population

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/ml

Measure	Adolescents, Cohort 1: 300 mg Oral Omadacycline n = 7	Children, Cohort 2: 300 mg Oral Omadacycline n = 4
Value	6550 (91.6)	9860 (84.9)

Population analysed: Pharmacokinetic Evaluable Population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents, Cohort 1: 100 mg IV Omadacycline	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Adolescents, Cohort 1: 300 mg Oral Omadacycline	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Cohort 2 Children 100 mg IV Omadacycline	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cohort 2 Children 300 mg Oral Omadacycline	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Manley study director

Paratek Pharmaceuticals Inc

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet in people with Bacterial Infections, run by Paratek Pharmaceuticals Inc at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.