Study to Evaluate the PK of IV and PO Omadacycline in Chi... | NCT05217537

NCT05217537

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Omadacycline Injection [Nuzyra]	Drug	Single dose of 100 mg omadacycline IV in 100 mL of normal saline	Cohort 1 (adolescents) Cohort 2 (children)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Amy Manley	Paratek Pharmaceuticals Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site 109		Little Rock	Arkansas	72202	United States
Site 112

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered intravenously (IV) with 100 milligrams (mg) Omadacycline for over 30 minutes.
FG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 14, 2023	Jan 20, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants received Omadacycline 300 mg tablets orally in a fasted state.

Safety Analysis Population includes all participants who have received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
BG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
BG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
BG003	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0017 BG0026 BG0034 BG00423

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.7± 0.82 BG00115.1± 1.46 BG0029.5± 1.38 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*nanograms per milliliter (h*ng/ml)

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG0006 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0008990± 27.3 OG00113300± 40.1

Primary

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.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms/milliliter (ng/ml)

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/ml

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Median

Full Range

hours

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Median

Full Range

hours

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG001	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

liters

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Primary

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.

Pharmacokinetic Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per hour (L/h)

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

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.

Units	Counts
Participants	OG000

Secondary

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.

Safety Population

Posted

Count of Participants

Participants

Up to Day 7

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline

Secondary

Number of Participants Reporting TEAE by Severity

Safety Population

Posted

Count of Participants

Participants

Up to Day 7

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Secondary

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.

Safety Population

Posted

Number

participants

Up to Day 7

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003

Secondary

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.

Safety Population.

Posted

Count of Participants

Participants

Up to Day 2

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline

Secondary

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).

Safety Population.

Posted

Count of Participants

Participants

Up to Day 2

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline

Secondary

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.

Safety Population.

Posted

Count of Participants

Participants

Up to Day 2

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Secondary

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.

Safety Population

Posted

Count of Participants

Participants

Up to Day 2

ID	Title	Description
OG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.
OG002	Children, Cohort 2: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
OG003	Children, Cohort 2: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Adolescents, Cohort 1: 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.	6	6	3	6
EG001	Adolescents, Cohort 1: 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.	7	7	4	7
EG002	Cohort 2 Children 100 mg IV Omadacycline	Participants were administered IV with 100 mg Omadacycline for over 30 minutes.	6	6	4	6
EG003	Cohort 2 Children 300 mg Oral Omadacycline	Participants received Omadacycline 300 mg tablets orally in a fasted state.	4	4	3	4

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0021 events1 affected6 at risk EG0030 events0 affected4 at risk
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0021 events1 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0021 events1 affected6 at risk EG003
Infusion site pain	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Infusion site pruritus	General disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Amylase increased	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Lipase increased	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected7 at risk EG0021 events1 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Lethargy	Nervous system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Flushing	Vascular disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0021 events1 affected6 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Yellow Skin	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003
Expired product administered	Injury, poisoning and procedural complications	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0021 events1 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0021 events1 affected6 at risk EG003
Irritability	Psychiatric disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0021 events1 affected6 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Non-systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected7 at risk EG0020 events0 affected6 at risk EG003

ID	Term
D001424	Bacterial Infections

ID	Term
C000591640	omadacycline

Participants received Omadacycline 300 mg tablets orally in a fasted state.