Trial Outcomes & Findings for Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections (NCT NCT05217537)
NCT ID: NCT05217537
Last Updated: 2026-03-09
Results Overview
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Results posted on
2026-03-09
Participant Flow
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
A total of 23 participants were enrolled in the study.
Participant milestones
| Measure |
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Adolescents, Cohort 1: 100 mg IV Omadacycline
Participants were administered intravenously (IV) with 100 milligrams (mg) Omadacycline for over 30 minutes.
|
Adolescents, Cohort 1: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
Baseline characteristics by cohort
| Measure |
Adolescents, Cohort 1: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 0.82 • n=68 Participants
|
15.1 years
STANDARD_DEVIATION 1.46 • n=69 Participants
|
9.5 years
STANDARD_DEVIATION 1.38 • n=137 Participants
|
10.5 years
STANDARD_DEVIATION 1.00 • n=565 Participants
|
12.7 years
STANDARD_DEVIATION 2.81 • n=127 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
8 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=68 Participants
|
6 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
3 Participants
n=565 Participants
|
15 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
8 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
3 Participants
n=565 Participants
|
15 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
6 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
2 Participants
n=565 Participants
|
11 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=565 Participants
|
4 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population include all participants who received study drug and have at least one evaluable pharmacokinetic parameter.
Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion
|
8990 hours*nanograms per milliliter (h*ng/ml)
Geometric Coefficient of Variation 27.3
|
13300 hours*nanograms per milliliter (h*ng/ml)
Geometric Coefficient of Variation 40.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=1 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
AUC(0-48) of Omadacycline After Oral Administration
|
6860 h*ng/ml
Geometric Coefficient of Variation 81.5
|
17900 h*ng/ml
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation cannot be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion
|
9010 h*ng/ml
Geometric Coefficient of Variation 27.4
|
13300 h*ng/ml
Geometric Coefficient of Variation 40.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
AUClast of Omadacycline After Oral Administration
|
6550 h*ng/ml
Geometric Coefficient of Variation 91.6
|
9860 h*ng/ml
Geometric Coefficient of Variation 84.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion
|
9720 h*ng/ml
Geometric Coefficient of Variation 28.1
|
14100 h*ng/ml
Geometric Coefficient of Variation 38.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=1 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
AUC0-inf of Omadacycline After Oral Administration
|
7450 h*ng/ml
Geometric Coefficient of Variation 86.9
|
18600 h*ng/ml
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation cannot be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion
|
1270 nanograms/milliliter (ng/ml)
Geometric Coefficient of Variation 29.1
|
1600 nanograms/milliliter (ng/ml)
Geometric Coefficient of Variation 51.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Cmax of Omadacycline After Oral Administration
|
528 ng/ml
Geometric Coefficient of Variation 69.4
|
946 ng/ml
Geometric Coefficient of Variation 42.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion
|
0.66 hours
Interval 0.58 to 0.73
|
0.81 hours
Interval 0.73 to 1.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Tmax of Omadacycline After Oral Administration
|
2.98 hours
Interval 2.0 to 3.13
|
2.00 hours
Interval 1.03 to 3.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion
|
12.9 hours
Geometric Coefficient of Variation 13.5
|
11.9 hours
Geometric Coefficient of Variation 11.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosingPopulation: Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=1 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
t1/2 of Omadacycline After Oral Administration
|
12.7 hours
Geometric Coefficient of Variation 31.2
|
10.7 hours
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation cannot be calculated for a single participant.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion
|
191 liters
Geometric Coefficient of Variation 27.7
|
122 liters
Geometric Coefficient of Variation 48.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 infusionPopulation: Pharmacokinetic Evaluable Population
Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Systemic Clearance (CL) of Omadacycline After IV Infusion
|
10.3 Liters per hour (L/h)
Geometric Coefficient of Variation 28.1
|
7.10 Liters per hour (L/h)
Geometric Coefficient of Variation 38.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: Safety Population
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.
Not Related
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.
Related
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 7Population: Safety Population
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants Reporting TEAE by Severity
Mild
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting TEAE by Severity
Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting TEAE by Severity
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 7Population: Safety Population
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug
Any TEAE
|
3 participants
|
4 participants
|
4 participants
|
3 participants
|
|
Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug
Any SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug
AE leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population.
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Hematology Parameters
Hematocrit
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Hemoglobin
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Leukocytes
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Platelets
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Mean cell volume
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Platelet count
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
White blood cell counts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Lymphocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Eosinophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Monocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Hematology Parameters
Basophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population.
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).
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Amylase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Lipase
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
ALT
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
AST
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Bicarbonate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Potassium
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Urate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Blood glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Urea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Sodium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Chloride
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
AP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Total bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Total protein
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Albumin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
CK
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Calcium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Phosphate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
Cholesterol
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Serum Chemistry Parameters
GGT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population.
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Vital Signs
Blood pressure
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Vital Signs
Heart rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Vital Signs
Oral body temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2Population: Safety Population
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.
Outcome measures
| Measure |
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=6 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=7 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Children, Cohort 2: 100 mg IV Omadacycline
n=6 Participants
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Children, Cohort 2: 300 mg Oral Omadacycline
n=4 Participants
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Adolescents, Cohort 1: 100 mg IV Omadacycline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Adolescents, Cohort 1: 300 mg Oral Omadacycline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 Children 100 mg IV Omadacycline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 Children 300 mg Oral Omadacycline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adolescents, Cohort 1: 100 mg IV Omadacycline
n=6 participants at risk
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Adolescents, Cohort 1: 300 mg Oral Omadacycline
n=7 participants at risk
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
Cohort 2 Children 100 mg IV Omadacycline
n=6 participants at risk
Participants were administered IV with 100 mg Omadacycline for over 30 minutes.
|
Cohort 2 Children 300 mg Oral Omadacycline
n=4 participants at risk
Participants received Omadacycline 300 mg tablets orally in a fasted state.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
50.0%
2/4 • Number of events 2 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
General disorders
Infusion site pain
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
General disorders
Infusion site pruritus
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 2 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Investigations
Amylase increased
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
14.3%
1/7 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Yellow Skin
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Expired product administered
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
16.7%
1/6 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/4 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/7 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
0.00%
0/6 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up to Day 7
Serious TEAEs and TEAEs were collected in the safety analysis population, which comprised of all participants who received at least one dose of study drug
|
Additional Information
Paratek Medical Information
Paratek Pharmaceuticals Inc
Phone: 1-833-727-2835
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place