A Phase 1 interventional study of Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet in Bacterial Infections, sponsored by Paratek Pharmaceuticals Inc. Completed at 9 sites in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Paratek Pharmaceuticals Inc · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
12 to \< 18 years of age
Drug: Omadacycline Injection [Nuzyra] · Drug: Omadacycline Oral Tablet
8 to \< 12 years of age
Drug: Omadacycline Injection [Nuzyra] · Drug: Omadacycline Oral Tablet
Single dose of 100 mg omadacycline IV in 100 mL of normal saline
Also known as: NUZYRA
Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)
Also known as: NUZYRA
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
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
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
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, 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
This was an open-label, multi-center study in children and adolescent participants with suspected or confirmed bacterial infections who had received concomitant systemic antibacterial therapy. The study consisted of 2 age cohorts: Cohort 1 (adolescents): 12 to \< 18 years of age and Cohort 2 (children): 8 to \< 12 years of age
| Milestone | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Started | 6 | 7 | 6 | 4 |
| Completed | 6 | 7 | 6 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| hours*nanograms per milliliter (h*ng/ml) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | 8990 ± 27.3 | 13300 ± 40.1 |
Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| h*ng/ml | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| AUC(0-48) of Omadacycline After Oral Administration | 6860 ± 81.5 | 17900 ± NA |
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| h*ng/ml | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | 9010 ± 27.4 | 13300 ± 40.2 |
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| h*ng/ml | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| AUClast of Omadacycline After Oral Administration | 6550 ± 91.6 | 9860 ± 84.9 |
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| h*ng/ml | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | 9720 ± 28.1 | 14100 ± 38.5 |
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| h*ng/ml | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| AUC0-inf of Omadacycline After Oral Administration | 7450 ± 86.9 | 18600 ± NA |
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| nanograms/milliliter (ng/ml) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion | 1270 ± 29.1 | 1600 ± 51.6 |
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| ng/ml | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| Cmax of Omadacycline After Oral Administration | 528 ± 69.4 | 946 ± 42.7 |
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| hours | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion | 0.66 (0.58 to 0.73) | 0.81 (0.73 to 1.08) |
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| hours | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| Tmax of Omadacycline After Oral Administration | 2.98 (2.00 to 3.13) | 2.00 (1.03 to 3.00) |
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.
| hours | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion | 12.9 ± 13.5 | 11.9 ± 11.8 |
Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| hours | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|
| t1/2 of Omadacycline After Oral Administration | 12.7 ± 31.2 | 10.7 ± NA |
Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| liters | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion | 191 ± 27.7 | 122 ± 48.0 |
Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
| Liters per hour (L/h) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline |
|---|---|---|
| Systemic Clearance (CL) of Omadacycline After IV Infusion | 10.3 ± 28.1 | 7.10 ± 38.5 |
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.
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Not Related | 0 | 2 | 1 | 1 |
| Related | 3 | 2 | 3 | 2 |
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.
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Mild | 2 | 4 | 4 | 0 |
| Moderate | 1 | 0 | 0 | 3 |
| Severe | 0 | 0 | 0 | 0 |
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.
| participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Any TEAE | 3 | 4 | 4 | 3 |
| Any SAE | 0 | 0 | 0 | 0 |
| AE leading to discontinuation | 0 | 0 | 0 | 0 |
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.
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Hematocrit | 2 | 0 | 0 | 0 |
| Hemoglobin | 3 | 0 | 0 | 0 |
| Leukocytes | 0 | 1 | 1 | 0 |
| Platelets | 0 | 0 | 1 | 0 |
| Mean cell volume | 0 | 0 | 0 | 0 |
| Platelet count | 0 | 0 | 0 | 0 |
| White blood cell counts | 0 | 0 | 0 | 0 |
| Neutrophils | 0 | 0 | 0 | 0 |
| Lymphocytes | 0 | 0 | 0 | 0 |
| Eosinophils | 0 | 0 | 0 | 0 |
| Monocytes | 0 | 0 | 0 | 0 |
| Basophils | 0 | 0 | 0 | 0 |
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).
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Amylase | 1 | 0 | 0 | 0 |
| Lipase | 1 | 0 | 1 | 0 |
| ALT | 0 | 0 | 3 | 1 |
| AST | 0 | 0 | 3 | 1 |
| Bicarbonate | 0 | 0 | 1 | 0 |
| Potassium | 0 | 0 | 2 | 0 |
| Urate | 0 | 0 | 1 | 0 |
| Blood glucose | 0 | 0 | 0 | 0 |
| Urea | 0 | 0 | 0 | 0 |
| Creatinine | 0 | 0 | 0 | 0 |
| Sodium | 0 | 0 | 0 | 0 |
| Chloride | 0 | 0 | 0 | 0 |
| AP | 0 | 0 | 0 | 0 |
| Total bilirubin | 0 | 0 | 0 | 0 |
| Total protein | 0 | 0 | 0 | 0 |
| Albumin | 0 | 0 | 0 | 0 |
| CK | 0 | 0 | 0 | 0 |
| Calcium | 0 | 0 | 0 | 0 |
| Phosphate | 0 | 0 | 0 | 0 |
| Cholesterol | 0 | 0 | 0 | 0 |
| GGT | 0 | 0 | 0 | 0 |
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.
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Blood pressure | 1 | 0 | 0 | 0 |
| Heart rate | 0 | 0 | 0 | 0 |
| Oral body temperature | 0 | 0 | 0 | 0 |
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.
| Participants | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Physical Examination | 0 | 0 | 0 | 0 |
Collected over Up to Day 7. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adolescents, Cohort 1: 100 mg IV Omadacycline | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Adolescents, Cohort 1: 300 mg Oral Omadacycline | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Cohort 2 Children 100 mg IV Omadacycline | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Cohort 2 Children 300 mg Oral Omadacycline | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Cohort 2 Children 100 mg IV Omadacycline | Cohort 2 Children 300 mg Oral Omadacycline |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 0/6 | 1/7 | 1/6 | 2/4 |
| NauseaGastrointestinal disorders | 0/6 | 1/7 | 1/6 | 1/4 |
| RashSkin and subcutaneous tissue disorders | 1/6 | 0/7 | 0/6 | 1/4 |
| Hepatic enzyme increasedInvestigations | 0/6 | 0/7 | 0/6 | 1/4 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/6 | 0/7 | 0/6 | 1/4 |
| Yellow SkinSkin and subcutaneous tissue disorders | 0/6 | 0/7 | 0/6 | 1/4 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/6 | 0/7 | 0/6 | 1/4 |
| ConstipationGastrointestinal disorders | 1/6 | 0/7 | 1/6 | 0/4 |
| Infusion site painGeneral disorders | 1/6 | 0/7 | 0/6 | 0/4 |
| Infusion site pruritusGeneral disorders | 1/6 | 0/7 | 0/6 | 0/4 |
Safety Analysis Population includes all participants who have received at least one dose of study drug.
| Age, Continuous(years) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline | Total |
|---|---|---|---|---|---|
| Mean | 14.7 ± 0.82 | 15.1 ± 1.46 | 9.5 ± 1.38 | 10.5 ± 1.00 | 12.7 ± 2.81 |
| Sex: Female, Male(Participants) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline | Total |
|---|---|---|---|---|---|
| Female | 2 | 1 | 4 | 1 | 8 |
| Male | 4 | 6 | 2 | 3 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 2 | 1 | 8 |
| Not Hispanic or Latino | 3 | 5 | 4 | 3 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Adolescents, Cohort 1: 100 mg IV Omadacycline | Adolescents, Cohort 1: 300 mg Oral Omadacycline | Children, Cohort 2: 100 mg IV Omadacycline | Children, Cohort 2: 300 mg Oral Omadacycline | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 0 | 2 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 2 | 1 | 6 |
| White | 3 | 3 | 3 | 2 | 11 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 0 | 1 | 4 |
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Paratek Pharmaceuticals Inc